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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085742
Company: MUTUAL PHARM
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
07/13/1977 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
12/01/1998 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

10/16/1995 SUPPL-64 Labeling

Label is not available on this site.

12/23/1994 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

09/03/1993 SUPPL-61 Labeling

Label is not available on this site.

04/03/1992 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

01/31/1992 SUPPL-57 Labeling

Label is not available on this site.

12/30/1991 SUPPL-56 Labeling

Label is not available on this site.

02/28/1990 SUPPL-55 Labeling

Label is not available on this site.

02/28/1990 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/03/1986 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

11/18/1985 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/18/1985 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

04/07/1989 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/11/1982 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/11/1982 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

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