Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202758
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription AP 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
04/23/2013 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
08/25/2020 SUPPL-6 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/25/2020 SUPPL-5 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

09/11/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS; EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AP 020080 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 202758 AUROBINDO PHARMA LTD
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 079242 FRESENIUS KABI USA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 200183 HIKMA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 090314 MYLAN ASI
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 077332 PAR PHARM
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 079123 WEST-WARD PHARMS INT
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 078593 WOCKHARDT

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