Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088887
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG 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
09/26/1984 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/25/2001 SUPPL-19 Labeling

Label is not available on this site.

10/05/2000 SUPPL-17 Labeling

Label is not available on this site.

07/07/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

05/24/1995 SUPPL-15 Labeling

Label is not available on this site.

07/14/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-13 Labeling

Label is not available on this site.

05/11/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/04/1993 SUPPL-11 Labeling

Label is not available on this site.

05/26/1992 SUPPL-10 Labeling

Label is not available on this site.

10/26/1990 SUPPL-8 Labeling

Label is not available on this site.

02/14/1990 SUPPL-7 Bioequivalence

Label is not available on this site.

07/29/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/22/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/17/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/17/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/17/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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