Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089399
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG 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
07/14/1987 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-43 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

11/21/2007 SUPPL-34 Labeling

Label is not available on this site.

06/29/2007 SUPPL-33 Labeling

Label is not available on this site.

04/12/2007 SUPPL-32 Labeling

Label is not available on this site.

04/12/2007 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/26/2005 SUPPL-26 Labeling

Label is not available on this site.

05/05/2005 SUPPL-25 Labeling

Label is not available on this site.

09/30/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2001 SUPPL-13 Labeling

Label is not available on this site.

07/05/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/22/1995 SUPPL-6 Labeling

Label is not available on this site.

06/22/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/16/1993 SUPPL-3 Labeling

Label is not available on this site.

05/15/1992 SUPPL-2 Labeling

Label is not available on this site.

02/27/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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