Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020071
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESOGEN DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-21 Discontinued None No No
DESOGEN DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/10/1992 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020071s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020071Orig1s025ltr.pdf
11/30/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/12/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/11/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/07/2007 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020071s017ltr.pdf
03/08/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/2004 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20071s014ltr.pdf
11/27/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/19/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/24/1998 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/20/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1997 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1998 SUPPL-8 Labeling

Label is not available on this site.

07/26/1996 SUPPL-7 Labeling

Label is not available on this site.

04/25/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/18/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/03/1995 SUPPL-4 Labeling

Label is not available on this site.

04/28/1995 SUPPL-2 Labeling

Label is not available on this site.

03/09/1993 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020071s025lbl.pdf
06/07/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf

DESOGEN

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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