Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 086153
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG 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
04/26/1978 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
05/07/2002 SUPPL-39 Labeling

Label is not available on this site.

01/29/2001 SUPPL-38 Labeling

Label is not available on this site.

03/12/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-33 Labeling

Label is not available on this site.

04/24/1995 SUPPL-32 Labeling

Label is not available on this site.

06/01/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/24/1993 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-27 Labeling

Label is not available on this site.

11/14/1991 SUPPL-25 Labeling

Label is not available on this site.

01/31/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/18/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/02/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/15/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/19/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/19/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

AMITRIPTYLINE HYDROCHLORIDE

TABLET; ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET; ORAL Prescription No AB 086153 MYLAN

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