Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085743
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG 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-67 Manufacturing (CMC)

Label is not available on this site.

10/16/1995 SUPPL-66 Labeling

Label is not available on this site.

12/23/1994 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

09/03/1993 SUPPL-63 Labeling

Label is not available on this site.

04/03/1992 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/31/1992 SUPPL-59 Labeling

Label is not available on this site.

12/30/1991 SUPPL-58 Labeling

Label is not available on this site.

02/28/1990 SUPPL-57 Labeling

Label is not available on this site.

02/28/1990 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

09/29/1987 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

03/20/1987 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

02/27/1986 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/05/1986 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

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