Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202931
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FROVATRIPTAN SUCCINATE FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/28/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2019 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/22/2019 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

FROVATRIPTAN SUCCINATE

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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