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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021006
Company: ENDO OPERATIONS

Other Important Information from FDA

Products on NDA 021006

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FROVA	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021006

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/08/2001	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2018	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021006s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021006Orig1s022ltr.pdf
11/15/2016	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/27/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/11/2013	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021006s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021006Orig1s019ltr.pdf
09/30/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/03/2009	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf
03/03/2009	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf
03/03/2009	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021006s006,s009,s010ltr.pdf
09/26/2005	SUPPL-5	Labeling		Label is not available on this site.

Labels for NDA 021006

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2018	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021006s022lbl.pdf
10/11/2013	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021006s019lbl.pdf
03/03/2009	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf
03/03/2009	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf
03/03/2009	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021006s006s009s010lbl.pdf
11/08/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-006_Frova_prntlbl.pdf

Therapeutic Equivalents for NDA 021006

FROVA

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FROVA	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	021006	ENDO OPERATIONS
FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	211292	AMNEAL PHARMS CO
FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	204730	GLENMARK PHARMS LTD
FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	213891	RENATA

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