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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021876
Company: DUCHESNAY

Summary Review

Products on NDA 021876

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLEGIS	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021876

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021876Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2022	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021876Orig1s016ltr.pdf
06/18/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021876s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021876Orig1s013ltr.pdf
03/10/2016	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/10/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/23/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/16/2014	SUPPL-6	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021876Orig1s006ltr.pdf
11/24/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/30/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/28/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/30/2013	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf
01/29/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021876

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2022	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
10/31/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
10/31/2022	SUPPL-16	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021876s016lbl.pdf
06/18/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021876s013lbl.pdf
09/30/2013	SUPPL-2	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf
04/08/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s000lbl.pdf

Therapeutic Equivalents for NDA 021876

DICLEGIS

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	207825	MYLAN PHARMS INC
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	208518	PAR PHARM INC

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