An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071259
Company: TEVA

Products on ANDA 071259

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIMETHOPRIM	TRIMETHOPRIM	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071259

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/1987	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
03/27/2012	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/071259s027lbl.pdf
05/15/2002	SUPPL-18	Labeling		Label is not available on this site.
05/15/2002	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/2002	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/15/2002	SUPPL-15	Manufacturing (CMC)-Facility		Label is not available on this site.
05/15/2002	SUPPL-14	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
07/07/2000	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
05/16/2000	SUPPL-12	Manufacturing (CMC)-Facility		Label is not available on this site.
03/06/1997	SUPPL-11	Labeling		Label is not available on this site.
04/16/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/05/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/17/1995	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/17/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/01/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/10/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/28/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 071259

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2012	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/071259s027lbl.pdf

Top