Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085032
Company: ANI PHARMS INC
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
11/19/1976 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
04/25/2016 SUPPL-309 Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-308 Labeling-Package Insert

Label is not available on this site.

06/18/1997 SUPPL-307 Manufacturing (CMC)

Label is not available on this site.

07/11/1995 SUPPL-306 Labeling

Label is not available on this site.

02/15/1995 SUPPL-305 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-304 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-303 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-302 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-301 Manufacturing (CMC)

Label is not available on this site.

03/23/1994 SUPPL-300 Manufacturing (CMC)

Label is not available on this site.

08/18/1993 SUPPL-299 Labeling

Label is not available on this site.

06/12/1992 SUPPL-298 Labeling

Label is not available on this site.

12/31/1991 SUPPL-295 Labeling

Label is not available on this site.

06/10/1992 SUPPL-294 Manufacturing (CMC)

Label is not available on this site.

04/05/1989 SUPPL-293 Manufacturing (CMC)

Label is not available on this site.

04/05/1989 SUPPL-292 Manufacturing (CMC)

Label is not available on this site.

03/31/1988 SUPPL-290 Manufacturing (CMC)

Label is not available on this site.

09/30/1987 SUPPL-288 Manufacturing (CMC)

Label is not available on this site.

11/04/1987 SUPPL-287 Manufacturing (CMC)

Label is not available on this site.

09/30/1987 SUPPL-285 Manufacturing (CMC)

Label is not available on this site.

04/28/1986 SUPPL-284 Manufacturing (CMC)

Label is not available on this site.

04/28/1986 SUPPL-283 Manufacturing (CMC)

Label is not available on this site.

03/12/1986 SUPPL-282 Manufacturing (CMC)

Label is not available on this site.

03/12/1986 SUPPL-281 Manufacturing (CMC)

Label is not available on this site.

09/30/1987 SUPPL-280 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-279 Manufacturing (CMC)

Label is not available on this site.

09/11/1985 SUPPL-278 Manufacturing (CMC)

Label is not available on this site.

12/21/1984 SUPPL-276 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-275 Manufacturing (CMC)

Label is not available on this site.

07/27/1984 SUPPL-274 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-273 Manufacturing (CMC)

Label is not available on this site.

12/16/1983 SUPPL-271 Manufacturing (CMC)

Label is not available on this site.

02/28/1983 SUPPL-270 Manufacturing (CMC)

Label is not available on this site.

12/12/1983 SUPPL-263 Manufacturing (CMC)

Label is not available on this site.

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