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FDA Handbooks: Questions? John Cuspilich RA/QA

 

Information for Industry on Dietary Supplements

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Applications & Submissions

Related Resources

 

On-Site Training Seminars

Includes: Books, Travel, Hotels and Expenses and Certificates

1-Day Drug GMP Boot Camp

1-Day Device GMP Boot Camp

2-Day Drug GMP Boot Camp

2-Day Device GMP Boot Camp

3-Day Master GMP Boot Camp

3-Day Audit & 2 Day GMP Training

1-Day Part 11 / Validation
 





Whats New with CDER

Get the CDER Handbook
GMP

August 11, 2017

August 10, 2017

August 9, 2017

August 8, 2017

August 7, 2017

August 4, 2017

 


CDER Workshops, Meetings and Conferences

Upcoming

August 2017

  • Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act, August 23, 2017, 9 am to 4 pm, FDA White Oak campus, 10903 New Hampshire Ave, Building 31, Great Room (Room 1503), Silver Spring, MD 20903.  Meeting information

September 2017

  • Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population, September 12, 2017, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Meeting information
  • Pediatric Trial Design and Modeling: Moving into the next decade. September 8, 2017. Food and Drug Administration, 10903 New Hampshire Ave. Building 31, Great Room, Silver Spring, MD 20993. Meeting Information
  • FDA-ASCO: Hematology and Oncology Fellows Day Workshop, September 15, 2017, FDA White Oak Campus, Building 22, Conference Room 2205, Silver Spring MD, 20993. Meeting information

October 2017

  • Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop, October 2 - 3, 2017,  Silver Spring, MD 20993. Meeting information 
  • Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing, October 6, 2017 from 8:00 a.m. to 4:00 p.m. at FDA’s White Oak campus 10903 New Hampshire Ave, Building 31 (The Great Room 1503B+C), Silver Spring, MD 20903-0002. Meeting information
  • Overcoming Barriers to Product Development, Regulatory Approval and Commercialization of Affordable, High Quality, Generic Topical Dermatological Drug Products; Public Workshop October 20, 2017 (8:30am – 4:30pm) FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503 (Great Room) Silver Spring, Maryland 20993. Meeting information
  • CDER Rare Diseases Public Workshop: Strategies, Tools and Best Practices for Effective Advocacy in Rare Diseases Drug Development, October 30, 2017, FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503 (Great Room) Silver Spring, Maryland 20993. Meeting information 

Whats New with FDA

Upcoming Events

Press Announcements

July 2017

 


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

August 11, 2017

August 10, 2017

August 9, 2017

August 8, 2017

August 7, 2017

August 4, 2017


CDRH Workshops, Meetings and Conferences



Weekly Rule Changes

Monday - NONE
Tuesday - NONE
Wednesday - NONE
Thursday - NONE
Friday - NONE

Friday, August 11, 2017

Food and Drug Administration

NONE

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Thursday, August 10, 2017

Food and Drug Administration

  Notices
  Qualification of Medical Device Development Tools; Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability
  Pages 37456 - 37458 [FR DOC # 2017-16827] PDF | Text
 
  Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Guidance for Industry; Availability
  Pages 37459 - 37461 [FR DOC # 2017-16839] PDF | Text
 
  Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
  Pages 37458 - 37459 [FR DOC # 2017-16891] PDF | Text
 

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Wednesday, August 9, 2017

Food and Drug Administration

  Notices
  Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft Guidance for Industry; Availability
  Pages 37229 - 37230 [FR DOC # 2017-16719] PDF | Text
 
  Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Draft Guidance for Industry; Availability
  Pages 37232 - 37233 [FR DOC # 2017-16718] PDF | Text
 
  Benefit-Risk Assessments in Drug Regulatory Decision-Making; Public Meeting; Request for Comments
  Pages 37230 - 37232 [FR DOC # 2017-16720] PDF | Text
 

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Tuesday, August 8, 2017

Food and Drug Administration

  Notices
  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
  Pages 37098 - 37100 [FR DOC # 2017-16647] PDF | Text
 
  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations
  Pages 37100 - 37101 [FR DOC # 2017-16649] PDF | Text
 
  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
  Pages 37101 - 37103 [FR DOC # 2017-16648] PDF | Text

 

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Monday, August 7, 2017

Food and Drug Administration

  Notices
  Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case; Withdrawal of Notice
  Pages 36792 - 36792 [FR DOC # 2017-16561] PDF | Text
 
  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry-User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
  Pages 36795 - 36796 [FR DOC # 2017-16580] PDF | Text
 
  Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
  Pages 36797 - 36799 [FR DOC # 2017-16564] PDF | Text
 
  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements
  Pages 36799 - 36801 [FR DOC # 2017-16607] PDF | Text
 
  Product-Specific Guidances; Final Guidances for Industry; Availability
  Pages 36792 - 36794 [FR DOC # 2017-16581] PDF | Text
 
  Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
  Pages 36789 - 36790 [FR DOC # 2017-16518] PDF | Text
 
  Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
  Pages 36796 - 36797 [FR DOC # 2017-16519] PDF | Text
 
  Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR
  Pages 36790 - 36792 [FR DOC # 2017-16516] PDF | Text
 
  Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI
  Pages 36794 - 36795 [FR DOC # 2017-16515] PDF | Text
 

 

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On-Site Training Seminars

Includes: Books, Travel, Hotels and Expenses and Certificates

1-Day Drug GMP Boot Camp

1-Day Device GMP Boot Camp

2-Day Drug GMP Boot Camp

2-Day Device GMP Boot Camp

3-Day Master GMP Boot Camp

3-Day Audit & 2 Day GMP Training

1-Day Part 11 / Validation
 
 
 
 
 
 
 
 
 
 
 




The Week's Drug Approvals

August 10, 2017

Drug Name and
Application Number
Dosage Form/ Route Company
Glyxambi
NDA #206073
Tablet; Oral Boehringer Ingelheim
Glyxambi
NDA #206073
Tablet; Oral Boehringer Ingelheim
Janumet
NDA #022044
Tablet; Oral Merck Sharp Dohme
Janumet Xr
NDA #202270
Tablet, Extended Release; Oral Merck Sharp Dohme
Januvia
NDA #021995
Tablet; Oral Merck Sharp Dohme
Jentadueto
NDA #201281
Tablet; Oral Boehringer Ingelheim
Jentadueto Xr
NDA #208026
Tablet, Extended Release; Oral Boehringer Ingelheim
Krystexxa
BLA #125293
Injectable; Injection Crealta Pharms Llc
Plan B One-Step
NDA #021998
Tablet; Oral Teva Branded Pharm
Tradjenta
NDA #201280
Tablet; Oral Boehringer Ingelheim

August 9, 2017

Drug Name and
Application Number
Dosage Form/ Route Company
Adrenalin
NDA #204200
Injectable; Intramuscular, Intraocular, Subcutaneous Par Sterile Products
Adrenalin
NDA #204640
Injectable; Intramuscular, Subcutaneous Par Sterile Products
Afirmelle
ANDA #206886
Tablet; Oral-28 Aurobindo Pharma Ltd
Afirmelle
ANDA #206886
Tablet; Oral-28 Aurobindo Pharma Ltd
Alesse
NDA #020683
Tablet; Oral-21 Wyeth Pharms
Alesse
NDA #020683
Tablet; Oral-28 Wyeth Pharms
Altavera
ANDA #079102
Tablet; Oral-28 Sandoz
Aviane-21
ANDA #075796
Tablet; Oral-21 Duramed Pharms Barr
Aviane-28
ANDA #075796
Tablet; Oral-28 Duramed Pharms Barr
Ayuna
ANDA #206866
Tablet; Oral-28 Aurobindo Pharma Ltd
Ayuna
ANDA #206866
Tablet; Oral-28 Aurobindo Pharma Ltd
Balziva-28
ANDA #076238
Tablet; Oral-28 Barr
Bekyree
ANDA #202226
Tablet; Oral-28 Lupin Ltd
Bekyree
ANDA #202226
Tablet; Oral-28 Lupin Ltd
Beyaz
NDA #022532
Tablet; Oral Bayer Hlthcare
Brevicon 21-Day
NDA #017566
Tablet; Oral-21 Allergan Sales Llc
Brevicon 28-Day
NDA #017743
Tablet; Oral-28 Allergan Sales Llc
Briellyn
ANDA #090538
Tablet; Oral-28 Glenmark Generics
Briellyn
ANDA #090538
Tablet; Oral-28 Glenmark Generics
Cancidas
NDA #021227
Powder; Iv (Infusion) Merck
Cryselle
ANDA #075840
Tablet; Oral-21 Duramed Pharms Barr
Cryselle
ANDA #075840
Tablet; Oral-21 Duramed Pharms Barr
Cryselle
ANDA #075840
Tablet; Oral-28 Duramed Pharms Barr
Cryselle
ANDA #075840
Tablet; Oral-28 Duramed Pharms Barr
Cyclessa
NDA #021090
Tablet; Oral-28 Aspen Global Inc
Cyclessa
NDA #021090
Tablet; Oral-28 Aspen Global Inc
Desogen
NDA #020071
Tablet; Oral-21 Organon Usa Inc
Desogen
NDA #020071
Tablet; Oral-28 Organon Usa Inc
Desogestrel and Ethinyl Estradiol
ANDA #075256
Tablet; Oral-21 Duramed Pharms Barr
Desogestrel and Ethinyl Estradiol
ANDA #075256
Tablet; Oral-21 Duramed Pharms Barr
Desogestrel and Ethinyl Estradiol
ANDA #075256
Tablet; Oral-28 Duramed Pharms Barr
Desogestrel and Ethinyl Estradiol
ANDA #075256
Tablet; Oral-28 Duramed Pharms Barr
Desogestrel and Ethinyl Estradiol
ANDA #076915
Tablet; Oral-28 Watson Labs
Desogestrel and Ethinyl Estradiol
ANDA #076915
Tablet; Oral-28 Watson Labs
Desogestrel and Ethinyl Estradiol
ANDA #076916
Tablet; Oral-28 Mayne Pharma
Desogestrel and Ethinyl Estradiol
ANDA #076916
Tablet; Oral-28 Mayne Pharma
Desogestrel and Ethinyl Estradiol
ANDA #091234
Tablet; Oral-28 Novast Labs Ltd
Desogestrel and Ethinyl Estradiol
ANDA #202085
Tablet; Oral-28 Mylan Labs Ltd
Desogestrel and Ethinyl Estradiol
ANDA #202296
Tablet; Oral-28 Mylan Labs Ltd
Desogestrel and Ethinyl Estradiol
ANDA #206853
Tablet; Oral-28 Aurobindo Pharma Ltd
Desogestrel and Ethinyl Estradiol
ANDA #206853
Tablet; Oral-28 Aurobindo Pharma Ltd
Docetaxel
ANDA #207252
Injectable; Injection Jiangsu Hengrui Med
Elifemme
ANDA #202507
Tablet; Oral-28 Labs Leon Farma
Elifemme
ANDA #202507
Tablet; Oral-28 Labs Leon Farma
Elinest
ANDA #091105
Tablet; Oral-28 Novast Labs Ltd
Emend
NDA #022023
Powder; Intravenous Merck and Co Inc
Emoquette
ANDA #076675
Tablet; Oral-28 Vintage Pharms Llc
Emoquette
ANDA #076675
Tablet; Oral-28 Vintage Pharms Llc
Emoquette
ANDA #076675
Tablet; Oral-28 Vintage Pharms Llc
Enpresse-21
ANDA #075809
Tablet; Oral-21 Duramed Pharms Barr
Enpresse-28
ANDA #075809
Tablet; Oral-28 Duramed Pharms Barr
Enskyce
ANDA #201887
Tablet; Oral-28 Lupin Ltd
Estrostep 21
NDA #020130
Tablet; Oral-21 Apil
Estrostep Fe
NDA #020130
Tablet; Oral-28 Apil
Ethynodiol Diacetate and Ethinyl Estradiol
ANDA #204703
Tablet; Oral-28 Mylan Labs Ltd
Ethynodiol Diacetate and Ethinyl Estradiol
ANDA #204704
Tablet; Oral-28 Mylan Labs Ltd
Falmina
ANDA #090721
Tablet; Oral-28 Novast Labs Ltd
Femcon Fe
NDA #021490
Tablet, Chewable; Oral Apil
Gencept 10/11-21
ANDA #072694
Tablet; Oral-21 Barr
Gencept 10/11-21
ANDA #072694
Tablet; Oral-21 Barr
Gencept 10/11-28
ANDA #072697
Tablet; Oral-28 Barr
Gencept 10/11-28
ANDA #072697
Tablet; Oral-28 Barr
Gildagia
ANDA #078376
Tablet; Oral-28 Vintage Pharms
Isibloom
ANDA #202789
Tablet; Oral-28 Sandoz Inc
Kariva
ANDA #075863
Tablet; Oral-28 Barr
Kariva
ANDA #075863
Tablet; Oral-28 Barr
Kelnor
ANDA #076785
Tablet; Oral-28 Barr
Kelnor
ANDA #076785
Tablet; Oral-28 Barr
Kimidess
ANDA #076681
Tablet; Oral-28 Vintage Pharms
Kimidess
ANDA #076681
Tablet; Oral-28 Vintage Pharms
Kimidess
ANDA #076681
Tablet; Oral-28 Vintage Pharms
Kurvelo
ANDA #091408
Tablet; Oral-28 Lupin Ltd
Lessina-21
ANDA #075803
Tablet; Oral-21 Barr
Lessina-21
ANDA #075803
Tablet; Oral-21 Barr
Lessina-28
ANDA #075803
Tablet; Oral-28 Barr
Lessina-28
ANDA #075803
Tablet; Oral-28 Barr
Levonest
ANDA #090719
Tablet; Oral-28 Novast Labs Ltd
Levonorgestrel and Ethinyl Estradiol
ANDA #076625
Tablet; Oral-28 Mayne Pharma
Levonorgestrel and Ethinyl Estradiol
ANDA #076625
Tablet; Oral-28 Mayne Pharma
Levonorgestrel and Ethinyl Estradiol
ANDA #079218
Tablet; Oral Watson Labs
Levonorgestrel and Ethinyl Estradiol
ANDA #079218
Tablet; Oral Watson Labs
Levonorgestrel and Ethinyl Estradiol
ANDA #091425
Tablet; Oral-28 Lupin Ltd
Levonorgestrel and Ethinyl Estradiol
ANDA #091425
Tablet; Oral-28 Lupin Ltd
Levonorgestrel and Ethinyl Estradiol
ANDA #091663
Tablet; Oral-28 Mylan Labs Ltd
Levonorgestrel and Ethinyl Estradiol
ANDA #200245
Tablet; Oral-28 Mylan Labs Ltd
Levonorgestrel and Ethinyl Estradiol
ANDA #200248
Tablet; Oral-28 Lupin Ltd
Levonorgestrel and Ethinyl Estradiol
ANDA #200248
Tablet; Oral-28 Lupin Ltd
Levonorgestrel and Ethinyl Estradiol
ANDA #201095
Tablet; Oral-28 Amneal Pharms
Levonorgestrel and Ethinyl Estradiol
ANDA #201095
Tablet; Oral-28 Amneal Pharms
Levonorgestrel and Ethinyl Estradiol
ANDA #201108
Tablet; Oral-28 Amneal Pharms
Levonorgestrel and Ethinyl Estradiol
ANDA #202247
Tablet; Oral-28 Mylan Labs Ltd
Levonorgestrel and Ethinyl Estradiol
ANDA #202791
Tablet; Oral Glenmark Generics
Levonorgestrel and Ethinyl Estradiol
ANDA #202791
Tablet; Oral Glenmark Generics
Levora 0.15/30-21
ANDA #073592
Tablet; Oral-21 Watson Labs
Levora 0.15/30-28
ANDA #073594
Tablet; Oral-28 Mayne Pharma
Levora 0.15/30-28
ANDA #073594
Tablet; Oral-28 Mayne Pharma
Lo Loestrin Fe
NDA #022501
Tablet; Oral Apil
Lo Loestrin Fe
NDA #022501
Tablet; Oral Apil
Lo Loestrin Fe
NDA #022501
Tablet; Oral Apil
Lo Minastrin Fe
NDA #204654
Tablet, Chewable, Tablet; Oral Apil
Lo/Ovral Fe
NDA #018206
Tablet; Oral Cadence Health
Lo/Ovral
NDA #017612
Tablet; Oral-21 Pelagius
Lo/Ovral-28
NDA #017802
Tablet; Oral-28 Wyeth Pharms
Loestrin 21 1.5/30
NDA #017875
Tablet; Oral-21 Apil
Loestrin 21 1/20
NDA #017876
Tablet; Oral-21 Apil
Loestrin 24 Fe
NDA #021871
Tablet; Oral Apil
Loestrin Fe 1.5/30
NDA #017355
Tablet; Oral-28 Apil
Loestrin Fe 1/20
NDA #017354
Tablet; Oral-28 Apil
Loseasonique
NDA #022262
Tablet; Oral Teva Branded Pharm
Low-Ogestrel-21
ANDA #075288
Tablet; Oral-21 Mayne Pharma
Low-Ogestrel-21
ANDA #075288
Tablet; Oral-21 Mayne Pharma
Low-Ogestrel-28
ANDA #075288
Tablet; Oral-28 Mayne Pharma
Low-Ogestrel-28
ANDA #075288
Tablet; Oral-28 Mayne Pharma
Marlissa
ANDA #091452
Tablet; Oral-28 Glenmark Generics
Marlissa
ANDA #091452
Tablet; Oral-28 Glenmark Generics
Minastrin 24 Fe
NDA #203667
Tablet, Chewable; Oral Apil
Mircette
NDA #020713
Tablet; Oral-28 Teva Branded Pharm
Modicon 28
NDA #017735
Tablet; Oral-28 Janssen Pharms
Myzilra
ANDA #077502
Tablet; Oral-28 Vintage Pharms Llc
Myzilra
ANDA #077502
Tablet; Oral-28 Vintage Pharms Llc
Myzilra
ANDA #077502
Tablet; Oral-28 Vintage Pharms Llc
Nordette-21
NDA #018668
Tablet; Oral-21 Teva Branded Pharm
Nordette-28
NDA #018782
Tablet; Oral-28 Teva Branded Pharm
Norethin 1/35e-21
ANDA #071480
Tablet; Oral-21 Watson Pharms Teva
Norethin 1/35e-21
ANDA #071480
Tablet; Oral-21 Watson Pharms Teva
Norethindrone and Ethinyl Estradiol (10/11)
ANDA #071043
Tablet; Oral-21 Watson Labs
Norethindrone and Ethinyl Estradiol (10/11)
ANDA #071043
Tablet; Oral-21 Watson Labs
Norethindrone and Ethinyl Estradiol (10/11)
ANDA #071044
Tablet; Oral-28 Watson Labs Teva
Norethindrone and Ethinyl Estradiol (10/11)
ANDA #071044
Tablet; Oral-28 Watson Labs Teva
Norethindrone and Ethinyl Estradiol (7/14)
ANDA #071041
Tablet; Oral-21 Watson Labs Teva
Norethindrone and Ethinyl Estradiol (7/14)
ANDA #071041
Tablet; Oral-21 Watson Labs Teva
Norethindrone and Ethinyl Estradiol (7/14)
ANDA #071042
Tablet; Oral-28 Watson Labs
Norethindrone and Ethinyl Estradiol (7/14)
ANDA #071042
Tablet; Oral-28 Watson Labs
Norethindrone and Ethinyl Estradiol and Ferrous Fumarate
NDA #022573
Tablet, Chewable; Oral Apil
Norethindrone and Ethinyl Estradiol
ANDA #070684
Tablet; Oral-21 Watson Labs
Norethindrone and Ethinyl Estradiol
ANDA #070684
Tablet; Oral-21 Watson Labs
Norethindrone and Ethinyl Estradiol
ANDA #070685
Tablet; Oral-21 Watson Pharms Teva
Norethindrone and Ethinyl Estradiol
ANDA #078323
Tablet; Oral-28 Watson Labs
Norethindrone and Ethinyl Estradiol
ANDA #078323
Tablet; Oral-28 Watson Labs
Norethindrone and Ethinyl Estradiol
ANDA #078379
Tablet; Oral-21 Watson Labs
Norethindrone and Ethinyl Estradiol
ANDA #200897
Tablet; Oral-28 Mylan Labs Ltd
Norethindrone and Ethinyl Estradiol
ANDA #203006
Tablet; Oral-28 Mylan Labs Ltd
Norgestrel and Ethinyl Estradiol
ANDA #201828
Tablet; Oral-28 Mylan Labs Ltd
Norgestrel and Ethinyl Estradiol
ANDA #201828
Tablet; Oral-28 Mylan Labs Ltd
Norinyl 1+35 21-Day
NDA #017565
Tablet; Oral-21 Allergan Sales Llc
Norinyl 1+35 28-Day
NDA #017565
Tablet; Oral-28 Allergan Sales Llc
Norminest Fe
NDA #017948
Tablet; Oral Gd Searle Llc
Norquest Fe
NDA #018926
Tablet; Oral-28 Gd Searle Llc
Nuvaring
NDA #021187
Ring; Vaginal Organon Usa Inc
Nuvaring
NDA #021187
Ring; Vaginal Organon Usa Inc
Ogestrel 0.5/50-21
ANDA #075406
Tablet; Oral-21 Watson Labs
Ogestrel 0.5/50-28
ANDA #075406
Tablet; Oral-28 Watson Labs
Orsythia
ANDA #077099
Tablet; Oral-28 Vintage Pharms Llc
Orsythia
ANDA #077099
Tablet; Oral-28 Vintage Pharms Llc
Ortho Cyclen-21
NDA #019653
Tablet; Oral-21 Janssen Pharms
Ortho Cyclen-28
NDA #019653
Tablet; Oral-28 Janssen Pharms
Ortho Evra
NDA #021180
Film, Extended Release; Transdermal Janssen Pharms
Ortho Tri-Cyclen Lo
NDA #021241
Tablet; Oral-28 Janssen Pharms
Ortho Tri-Cyclen
NDA #019697
Tablet; Oral-21 Janssen Pharms
Ortho Tri-Cyclen
NDA #019697
Tablet; Oral-28 Janssen Pharms
Ortho-Cept
NDA #020301
Tablet; Oral-21 Janssen Pharms
Ortho-Cept
NDA #020301
Tablet; Oral-28 Janssen Pharms
Ortho-Novum 1/35-28
NDA #017919
Tablet; Oral-28 Janssen Pharms
Ortho-Novum 7/7/7-21
NDA #018985
Tablet; Oral-21 Janssen Pharms
Ortho-Novum 7/7/7-28
NDA #018985
Tablet; Oral-28 Janssen Pharms
Philith
ANDA #090947
Tablet; Oral-28 Novast Labs Ltd
Pimtrea
ANDA #091247
Tablet; Oral-28 Novast Labs Ltd
Portia-21
ANDA #075866
Tablet; Oral-21 Barr
Portia-21
ANDA #075866
Tablet; Oral-21 Barr
Portia-28
ANDA #075866
Tablet; Oral-28 Barr
Portia-28
ANDA #075866
Tablet; Oral-28 Barr
Quartette
NDA #204061
Tablet; Oral Teva Branded Pharm
Safyral
NDA #022574
Tablet; Oral Bayer Hlthcare
Seasonale
NDA #021544
Tablet; Oral Teva Branded Pharm
Seasonique
NDA #021840
Tablet; Oral Teva Branded Pharm
Taytulla
NDA #204426
Capsule; Oral Apil
Tri-Norinyl 21-Day
NDA #018977
Tablet; Oral-21 Mayne Pharma
Tri-Norinyl 28-Day
NDA #018977
Tablet; Oral-28 Mayne Pharma
Triphasil-21
NDA #019192
Tablet; Oral-21 Wyeth Pharms
Triphasil-28
NDA #019190
Tablet; Oral-28 Wyeth Pharms Inc
Trivora-21
ANDA #074538
Tablet; Oral-21 Mayne Pharma
Trivora-28
ANDA #074538
Tablet; Oral-28 Mayne Pharma
Vienva
ANDA #201088
Tablet; Oral-28 Sandoz Inc
Vienva
ANDA #201088
Tablet; Oral-28 Sandoz Inc
Viorele
ANDA #091346
Tablet; Oral-28 Glenmark Generics
Viorele
ANDA #091346
Tablet; Oral-28 Glenmark Generics
Volnea
ANDA #202689
Tablet; Oral-28 Sandoz Inc
Vyfemla
ANDA #201886
Tablet; Oral-28 Lupin Ltd
Vyfemla
ANDA #201886
Tablet; Oral-28 Lupin Ltd
Xulane
ANDA #200910
Film, Extended Release; Transdermal Mylan Technologies
Yasmin
NDA #021098
Tablet; Oral-28 Bayer Hlthcare
Yaz
NDA #021676
Tablet; Oral Bayer Hlthcare
Zovia 1/35e-21
ANDA #072720
Tablet; Oral-21 Watson Pharms Teva
Zovia 1/35e-21
ANDA #072720
Tablet; Oral-21 Watson Pharms Teva
Zovia 1/35e-28
ANDA #072721
Tablet; Oral-28 Mayne Pharma
Zovia 1/50e-21
ANDA #072722
Tablet; Oral-21 Watson Labs
Zovia 1/50e-21
ANDA #072722
Tablet; Oral-21 Watson Labs

August 8, 2017

Drug Name and
Application Number
Dosage Form/ Route Company
Advil Liqui-Gels
NDA #020402
Capsule; Oral Pfizer
Advil Migraine Liqui-Gels
NDA #020402
Capsule; Oral Pfizer
Argatroban
NDA #020883
Injectable; Injection Novartis Pharms Corp
Armodafinil
ANDA #202768
Tablet; Oral Natco Pharma Ltd
Diltiazem Hydrochloride
ANDA #206534
Capsule, Extended Release; Oral Zydus Pharms Usa Inc
Femring
NDA #021367
Insert, Extended Release; Vaginal Apil
Femring
NDA #021367
Insert, Extended Release; Vaginal Apil
Naloxone Hydrochloride
ANDA #207633
Injectable; Injection Somerset Theraps Llc

August 7, 2017

Drug Name and
Application Number
Dosage Form/ Route Company
Abacavir; Lamivudine
ANDA #208990
Tablet; Oral Zydus Pharms Usa Inc
Albuterol Sulfate and Ipratropium Bromide
ANDA #207875
Solution; Inhalation Sun Pharma Global
Diclofenac Sodium
ANDA #206715
Solution; Topical Riconpharma Llc
Homatropine Methylbromide and Hydrocodone Bitartrate
ANDA #207176
Tablet; Oral Avanthi Inc
Oxycodone Hydrochloride
ANDA #207418
Tablet; Oral Ascent Pharms Inc
Oxycodone Hydrochloride
ANDA #208795
Solution; Oral Hi-Tech Pharmacal
Zovia 1/50e-28
ANDA #072723
Tablet; Oral-28 Watson Labs
Zovia 1/50e-28
ANDA #072723
Tablet; Oral-28 Watson Labs
Zovia 1/50e-28
ANDA #072723
Tablet; Oral-28 Watson Labs