Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085836
Company: TEVA
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
08/02/1977 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
06/18/1997 SUPPL-167 Manufacturing (CMC)

Label is not available on this site.

07/11/1995 SUPPL-166 Labeling

Label is not available on this site.

02/15/1995 SUPPL-165 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-164 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-163 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-162 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-161 Manufacturing (CMC)

Label is not available on this site.

03/23/1994 SUPPL-160 Manufacturing (CMC)

Label is not available on this site.

08/18/1993 SUPPL-159 Labeling

Label is not available on this site.

06/12/1992 SUPPL-158 Labeling

Label is not available on this site.

12/31/1991 SUPPL-156 Labeling

Label is not available on this site.

06/10/1992 SUPPL-155 Manufacturing (CMC)

Label is not available on this site.

04/05/1989 SUPPL-153 Manufacturing (CMC)

Label is not available on this site.

03/31/1988 SUPPL-152 Manufacturing (CMC)

Label is not available on this site.

03/31/1988 SUPPL-151 Manufacturing (CMC)

Label is not available on this site.

09/30/1987 SUPPL-149 Manufacturing (CMC)

Label is not available on this site.

11/04/1987 SUPPL-148 Manufacturing (CMC)

Label is not available on this site.

09/30/1987 SUPPL-146 Manufacturing (CMC)

Label is not available on this site.

05/09/1986 SUPPL-145 Manufacturing (CMC)

Label is not available on this site.

05/09/1986 SUPPL-144 Manufacturing (CMC)

Label is not available on this site.

03/12/1986 SUPPL-143 Manufacturing (CMC)

Label is not available on this site.

03/12/1986 SUPPL-142 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-140 Manufacturing (CMC)

Label is not available on this site.

09/11/1985 SUPPL-139 Manufacturing (CMC)

Label is not available on this site.

12/21/1984 SUPPL-138 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-137 Manufacturing (CMC)

Label is not available on this site.

07/27/1984 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-135 Manufacturing (CMC)

Label is not available on this site.

07/07/1982 SUPPL-130 Manufacturing (CMC)

Label is not available on this site.

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