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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212728
Company: PFIZER

Products on NDA 212728

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NURTEC ODT	RIMEGEPANT SULFATE	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212728

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212728Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212728Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2022	SUPPL-14	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212728Orig1s014ltr.pdf
12/08/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212728Orig1s012ltr.pdf
04/11/2022	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212728s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212728Orig1s009ltr.pdf
05/27/2021	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212728Orig1s006ltr.pdf
08/18/2020	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212728Orig1s001ltr.pdf

Labels for NDA 212728

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2022	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212728s009lbl.pdf
12/08/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s012lbl.pdf
05/27/2021	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s006lbl.pdf
08/18/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s001lbl.pdf
02/27/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s000lbl.pdf

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