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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040167
Company: PERRIGO

Products on ANDA 040167

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 040167

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2024	SUPPL-52	Labeling-Container/Carton Labels		Label is not available on this site.
02/20/2024	SUPPL-51	Labeling-Container/Carton Labels		Label is not available on this site.
10/06/2023	SUPPL-50	Labeling-Container/Carton Labels		Label is not available on this site.
03/06/2015	SUPPL-43	Labeling-Package Insert		Label is not available on this site.
10/09/2014	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
06/02/2009	SUPPL-33	Labeling		Label is not available on this site.
07/14/2008	SUPPL-31	Labeling		Label is not available on this site.
09/10/2002	SUPPL-6	Labeling		Label is not available on this site.
10/04/2001	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
10/04/2001	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/21/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/10/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/10/1998	SUPPL-1	Manufacturing (CMC)		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

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