Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040564
Company: LNK

Products on ANDA 040564

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040564

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/2004	ORIG-1	Approval				Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

DOXYLAMINE SUCCINATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 25MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Over-the-counter	No	040564	LNK
DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Over-the-counter	No	040167	PERRIGO
UNISOM	DOXYLAMINE SUCCINATE	25MG	TABLET;ORAL	Over-the-counter	Yes	018066	CHATTEM