Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006412
Company: SANOFI AVENTIS US

Products on NDA 006412

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DECAPRYN	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Discontinued	None	No	No
DECAPRYN	DOXYLAMINE SUCCINATE	12.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 006412

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/1948	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.