Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017952
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIMPEX TRIMETHOPRIM 100MG TABLET;ORAL Discontinued None No No
TRIMPEX 200 TRIMETHOPRIM 200MG 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
05/30/1980 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/1997 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/17/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/20/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/01/1983 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1983 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/09/1982 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1983 SUPPL-5 Labeling

Label is not available on this site.

10/09/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1982 SUPPL-2 Labeling

Label is not available on this site.

10/28/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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