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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209661
Company: DUCHESNAY

Products on NDA 209661

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BONJESTA	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	20MG;20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209661

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209661lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209661Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209661Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2022	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209661Orig1s008ltr.pdf
02/23/2022	SUPPL-7	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661Orig1s007lbl.pdf
06/18/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209661s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209661Orig1s004ltr.pdf

Labels for NDA 209661

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661s008lbl.pdf
10/31/2022	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661s008lbl.pdf
10/31/2022	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661s008lbl.pdf
02/23/2022	SUPPL-7	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209661Orig1s007lbl.pdf
06/18/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209661s004lbl.pdf
11/07/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209661lbl.pdf

Therapeutic Equivalents for NDA 209661

BONJESTA

TABLET, EXTENDED RELEASE;ORAL; 20MG;20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BONJESTA	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	20MG;20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	209661	DUCHESNAY

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