Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075256
Company: DURAMED PHARMS BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-21 Discontinued None No No
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/12/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256_Desogestrel%20and%20Ethinyl%20Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75256ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075256_desogestrel_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-36 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/26/2016 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

01/31/2013 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

11/26/2004 SUPPL-8 Labeling

Label is not available on this site.

06/19/2002 SUPPL-7 Manufacturing (CMC)-Facility Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75256S007_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75256S007_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075256s007_desogestrel_toc.cfm
07/27/2001 SUPPL-6 Manufacturing (CMC)-Manufacturing Process Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S006_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S006_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s006_desogestrel_toc.cfm
07/27/2001 SUPPL-5 Manufacturing (CMC) Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S005_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S005_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s005_desogestrel_toc.cfm
07/11/2001 SUPPL-4 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S004_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S004_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s004_desogestrel_toc.cfm
11/14/2001 SUPPL-3 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s003_desogestrel_toc.cfm
06/28/2001 SUPPL-2 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075256s002_desogestral_toc.cfm
10/28/1999 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel%20and%20Ethinyl_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel%20and%20Ethinyl_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075256s001_desogestrel_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/19/2002 SUPPL-7 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75256S007_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
11/14/2001 SUPPL-3 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S003_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
07/27/2001 SUPPL-6 Manufacturing (CMC)-Manufacturing Process Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S006_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
07/27/2001 SUPPL-5 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S005_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
07/11/2001 SUPPL-4 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S004_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
06/28/2001 SUPPL-2 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75256S002_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
10/28/1999 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256S001_Desogestrel%20and%20Ethinyl_Prntlbl.pdf
08/12/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75256_Desogestrel%20and%20Ethinyl%20Estradiol_Prntlbl.pdf

DESOGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.15MG;0.03MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESOGEN DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 020071 ORGANON USA INC
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 075256 DURAMED PHARMS BARR
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 202085 MYLAN LABS LTD
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 091234 NOVAST LABS LTD
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 076915 WATSON LABS
EMOQUETTE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 076675 VINTAGE PHARMS LLC
ENSKYCE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 201887 LUPIN LTD
ISIBLOOM DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 202789 SANDOZ INC
KALLIGA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 207081 AUROBINDO PHARMA LTD

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