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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208518
Company: ENDO OPERATIONS

Products on ANDA 208518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208518Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208518

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

TABLET, DELAYED RELEASE;ORAL; 10MG;10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLEGIS	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	021876	DUCHESNAY
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	205811	ACTAVIS LABS FL INC
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217000	BIONPHARMA
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	208518	ENDO OPERATIONS
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	207825	MYLAN PHARMS INC

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