An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Discontinued	None	Yes	No

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.html

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

Top