Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019190
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIPHASIL-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-28 Discontinued None Yes No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
11/01/1984 ORIG-1 Approval Type 3 - New Dosage Form 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
05/08/2019 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019190s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017802Orig1s034, 017948Orig1s046, 018926Orig1s013, 019190Orig1s049, 019192Orig1s048ltr.pdf
08/09/2017 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019190s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019190Orig1s048ltr.pdf
03/06/2002 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/23/2000 SUPPL-36 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/019190s036lbl.pdf
12/11/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/02/2000 SUPPL-34 Labeling

Label is not available on this site.

03/11/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/25/1997 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/17/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/11/1995 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1995 SUPPL-29 Labeling

Label is not available on this site.

05/03/1995 SUPPL-28 Labeling

Label is not available on this site.

05/27/1994 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/04/1993 SUPPL-25 Labeling

Label is not available on this site.

03/09/1993 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/29/1993 SUPPL-23 Labeling

Label is not available on this site.

06/10/1992 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/03/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/30/1990 SUPPL-19 Labeling

Label is not available on this site.

05/15/1990 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/18/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/19/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/15/1991 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1988 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/08/1990 SUPPL-12 Labeling

Label is not available on this site.

10/27/1987 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/15/1987 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/15/1986 SUPPL-7 Labeling

Label is not available on this site.

10/07/1991 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1985 SUPPL-3 Labeling

Label is not available on this site.

09/06/1985 SUPPL-2 Labeling

Label is not available on this site.

07/29/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/08/2019 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019190s049lbl.pdf
08/09/2017 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019190s048lbl.pdf
03/23/2000 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/019190s036lbl.pdf

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