Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017952
Company: ROCHE

Products on NDA 017952

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017952

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.