Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016012
Company: TEVA WOMENS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIVACTIL PROTRIPTYLINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
VIVACTIL PROTRIPTYLINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
09/27/1967 ORIG-1 Approval Type 1 - New Molecular Entity 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
07/17/2014 SUPPL-53 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016012Orig1s053ltr.pdf
04/11/2000 SUPPL-52 Labeling

Label is not available on this site.

04/11/2000 SUPPL-51 Labeling

Label is not available on this site.

04/11/2000 SUPPL-50 Labeling

Label is not available on this site.

11/04/1998 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1997 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1996 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2000 SUPPL-46 Labeling

Label is not available on this site.

04/15/1996 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/27/2000 SUPPL-44 Labeling

Label is not available on this site.

06/01/1994 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/26/1993 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1988 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/13/1987 SUPPL-40 Labeling

Label is not available on this site.

03/18/1988 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1986 SUPPL-37 Labeling

Label is not available on this site.

09/20/1985 SUPPL-36 Labeling

Label is not available on this site.

07/16/1984 SUPPL-35 Labeling

Label is not available on this site.

06/09/1983 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1982 SUPPL-32 Labeling

Label is not available on this site.

03/06/1981 SUPPL-30 Labeling

Label is not available on this site.

03/10/1981 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/10/1981 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/12/1980 SUPPL-27 Labeling

Label is not available on this site.

01/29/1980 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/25/1978 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/1977 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1983 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

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