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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010911
Company: STUART PHARMS

Products on NDA 010911

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUCLADIN-S	BUCLIZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010911

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/1957	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

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