Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075969
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Discontinued None No No
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Discontinued None No No
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM 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
01/29/2002 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
11/14/2019 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

11/14/2019 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/08/2007 SUPPL-9 Labeling

Label is not available on this site.

06/18/2004 SUPPL-5 Labeling

Label is not available on this site.

01/02/2003 SUPPL-2 Labeling

Label is not available on this site.

11/06/2002 SUPPL-1 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