Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085744
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG 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
06/21/1977 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-78 Manufacturing (CMC)

Label is not available on this site.

10/16/1995 SUPPL-77 Labeling

Label is not available on this site.

12/23/1994 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

09/03/1993 SUPPL-74 Labeling

Label is not available on this site.

04/03/1992 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

01/31/1992 SUPPL-70 Labeling

Label is not available on this site.

12/30/1991 SUPPL-69 Labeling

Label is not available on this site.

02/28/1990 SUPPL-68 Labeling

Label is not available on this site.

02/28/1990 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

02/12/1988 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

03/05/1986 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

12/27/1985 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

03/05/1986 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

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