Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009319
Company: FOREST LABS

Products on NDA 009319

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMBENYL	BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE	12.5MG/5ML;10MG/5ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/1954	ORIG-1	Approval	Type 4 - New Combination	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
04/14/1993	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
09/22/1989	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1993	SUPPL-24	Labeling		Label is not available on this site.
08/26/1988	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
02/27/1986	SUPPL-21	Labeling		Label is not available on this site.
01/10/1984	SUPPL-18	Efficacy		Label is not available on this site.
01/10/1984	SUPPL-17	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/07/2007	SUPPL-16	Labeling		Label is not available on this site.
12/07/2007	SUPPL-14	Labeling		Label is not available on this site.
12/07/2007	SUPPL-13	Labeling		Label is not available on this site.
12/07/2007	SUPPL-12	Labeling		Label is not available on this site.
12/07/2007	SUPPL-11	Labeling		Label is not available on this site.
12/07/2007	SUPPL-9	Labeling		Label is not available on this site.
12/07/2007	SUPPL-8	Labeling		Label is not available on this site.
12/07/2007	SUPPL-6	Labeling		Label is not available on this site.