Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011418
Company: WYETH AYERST

Products on NDA 011418

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIMETANE-TEN	BROMPHENIRAMINE MALEATE	10MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1958	ORIG-1	Approval	Type 3 - New Dosage Form	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
06/03/1992	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
06/16/1988	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
08/13/1986	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
06/06/1984	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
12/18/1981	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
06/06/1981	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
11/21/1980	SUPPL-17	Labeling		Label is not available on this site.
02/01/1980	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/1979	SUPPL-15	Labeling		Label is not available on this site.
06/26/1979	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
12/07/1978	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/1978	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/26/1977	SUPPL-11	Labeling		Label is not available on this site.