Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085745
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG 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
07/11/1977 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-88 Manufacturing (CMC)

Label is not available on this site.

10/16/1995 SUPPL-87 Labeling

Label is not available on this site.

12/23/1994 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

09/03/1993 SUPPL-84 Labeling

Label is not available on this site.

04/03/1992 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

01/31/1992 SUPPL-80 Labeling

Label is not available on this site.

12/30/1991 SUPPL-79 Labeling

Label is not available on this site.

02/28/1990 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

02/28/1990 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

02/28/1990 SUPPL-76 Labeling

Label is not available on this site.

02/28/1990 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

08/12/1985 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

08/12/1985 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

08/12/1985 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

08/12/1985 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

05/11/1982 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

05/11/1982 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

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