Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074054
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Discontinued None No No
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Discontinued None No No
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Discontinued None No No
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;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
12/31/1992 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
02/08/2002 SUPPL-15 Labeling

Label is not available on this site.

11/06/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/09/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/05/1999 SUPPL-8 Labeling

Label is not available on this site.

04/05/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/29/1997 SUPPL-6 Labeling

Label is not available on this site.

12/12/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/31/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-3 Labeling

Label is not available on this site.

08/24/1993 SUPPL-2 Labeling

Label is not available on this site.

09/22/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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