Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071259
Company: TEVA
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TRIMETHOPRIM TRIMETHOPRIM 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
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.

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

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