Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070049
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIMETHOPRIM TRIMETHOPRIM 100MG 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
06/06/1985 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
10/27/2015 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

02/21/2007 SUPPL-15 Labeling

Label is not available on this site.

05/01/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2001 SUPPL-11 Labeling

Label is not available on this site.

02/26/1997 SUPPL-9 Labeling

Label is not available on this site.

12/23/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/09/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TRIMETHOPRIM

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET;ORAL Prescription Yes AB 018679 MAYNE PHARMA
TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET;ORAL Prescription No AB 091437 NOVEL LABS INC
TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET;ORAL Prescription No AB 070049 WATSON LABS

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