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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210296
Company: BANNER LIFE SCIENCES

Products on NDA 210296

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BAFIERTAM	MONOMETHYL FUMARATE	95MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210296

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2020	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210296s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210296Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/210296Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-6	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210296s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210296Orig1s005,s006ltr.pdf
12/13/2023	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210296s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210296Orig1s005,s006ltr.pdf
01/12/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210296s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210296Orig1s004ltr.pdf

Labels for NDA 210296

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210296s006lbl.pdf
12/13/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210296s005lbl.pdf
12/13/2023	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210296s005lbl.pdf
01/12/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210296s004lbl.pdf
04/28/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210296s000lbl.pdf

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