Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021006
Company: ENDO PHARMS
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
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.

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

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 PHARMS
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 202931 MYLAN

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