Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085031
Company: ANI PHARMS 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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/16/1976 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-287 Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-286 Labeling-Package Insert

Label is not available on this site.

06/18/1997 SUPPL-285 Manufacturing (CMC)

Label is not available on this site.

06/11/1995 SUPPL-284 Labeling

Label is not available on this site.

02/15/1995 SUPPL-283 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-282 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-281 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-280 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-279 Manufacturing (CMC)

Label is not available on this site.

03/23/1994 SUPPL-278 Manufacturing (CMC)

Label is not available on this site.

08/18/1993 SUPPL-277 Labeling

Label is not available on this site.

06/12/1992 SUPPL-276 Labeling

Label is not available on this site.

12/31/1991 SUPPL-273 Labeling

Label is not available on this site.

06/10/1992 SUPPL-272 Manufacturing (CMC)

Label is not available on this site.

04/05/1989 SUPPL-271 Manufacturing (CMC)

Label is not available on this site.

03/31/1988 SUPPL-269 Manufacturing (CMC)

Label is not available on this site.

03/31/1988 SUPPL-268 Manufacturing (CMC)

Label is not available on this site.

09/30/1987 SUPPL-266 Manufacturing (CMC)

Label is not available on this site.

11/04/1987 SUPPL-265 Manufacturing (CMC)

Label is not available on this site.

09/30/1987 SUPPL-263 Manufacturing (CMC)

Label is not available on this site.

04/28/1986 SUPPL-262 Manufacturing (CMC)

Label is not available on this site.

04/28/1986 SUPPL-261 Manufacturing (CMC)

Label is not available on this site.

03/12/1986 SUPPL-260 Manufacturing (CMC)

Label is not available on this site.

03/12/1986 SUPPL-259 Manufacturing (CMC)

Label is not available on this site.

12/19/1985 SUPPL-257 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-256 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-255 Manufacturing (CMC)

Label is not available on this site.

09/11/1985 SUPPL-254 Manufacturing (CMC)

Label is not available on this site.

12/21/1984 SUPPL-252 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-251 Manufacturing (CMC)

Label is not available on this site.

07/27/1984 SUPPL-250 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-249 Manufacturing (CMC)

Label is not available on this site.

12/16/1983 SUPPL-248 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-244 Manufacturing (CMC)

Label is not available on this site.

12/12/1983 SUPPL-239 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English