Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010799
Company: WYETH CONS

Products on NDA 010799

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIMETANE	BROMPHENIRAMINE MALEATE	4MG	TABLET;ORAL	Discontinued	None	No	No
DIMETANE	BROMPHENIRAMINE MALEATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DIMETANE	BROMPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010799

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/1957	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
04/14/1998	SUPPL-73	Manufacturing (CMC)		Label is not available on this site.
04/30/1996	SUPPL-71	Labeling		Label is not available on this site.
02/06/1996	SUPPL-70	Manufacturing (CMC)-Control		Label is not available on this site.
06/03/1992	SUPPL-69	Manufacturing (CMC)-Control		Label is not available on this site.
01/24/1989	SUPPL-68	Manufacturing (CMC)-Control		Label is not available on this site.
01/24/1989	SUPPL-67	Labeling		Label is not available on this site.
03/24/1988	SUPPL-66	Manufacturing (CMC)-Control		Label is not available on this site.
03/17/1988	SUPPL-65	Manufacturing (CMC)-Control		Label is not available on this site.
06/17/1986	SUPPL-64	Labeling		Label is not available on this site.
06/10/1986	SUPPL-63	Manufacturing (CMC)-Control		Label is not available on this site.
05/28/1985	SUPPL-62	Manufacturing (CMC)-Control		Label is not available on this site.
06/24/1985	SUPPL-60	Manufacturing (CMC)-Control		Label is not available on this site.
08/17/1984	SUPPL-59	Manufacturing (CMC)-Control		Label is not available on this site.
12/19/1984	SUPPL-58	Manufacturing (CMC)-Control		Label is not available on this site.
04/15/1983	SUPPL-57	Efficacy		Label is not available on this site.
04/15/1983	SUPPL-56	Manufacturing (CMC)-Control		Label is not available on this site.
08/17/1984	SUPPL-53	Manufacturing (CMC)-Control		Label is not available on this site.
07/10/1986	SUPPL-52	Manufacturing (CMC)-Control		Label is not available on this site.
09/04/1986	SUPPL-51	Manufacturing (CMC)-Control		Label is not available on this site.
06/10/1983	SUPPL-35	Labeling		Label is not available on this site.
06/10/1983	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.