Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085971
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription AB 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
11/29/1977 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
04/25/2016 SUPPL-78 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-75 Labeling-Package Insert

Label is not available on this site.

11/13/2007 SUPPL-68 Labeling

Label is not available on this site.

06/29/2007 SUPPL-67 Labeling

Label is not available on this site.

06/09/2005 SUPPL-65 Labeling

Label is not available on this site.

06/25/2001 SUPPL-63 Labeling

Label is not available on this site.

08/07/2000 SUPPL-61 Labeling

Label is not available on this site.

04/10/1995 SUPPL-57 Labeling

Label is not available on this site.

08/27/1993 SUPPL-55 Labeling

Label is not available on this site.

12/15/1992 SUPPL-54 Labeling

Label is not available on this site.

AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 086009 MYLAN
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 085968 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 085971 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 089399 SUN PHARM INDS INC
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 040218 VINTAGE PHARMS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS

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