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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204090
Company: EMCURE PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET;ORAL Discontinued None No No
RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET;ORAL Discontinued None 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
11/26/2013 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
11/29/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/29/2019 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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