Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076554
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription AB No No
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG 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
08/10/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076554s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/23/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/10/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

02/18/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

SUMATRIPTAN SUCCINATE

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 020132 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 200263 APOTEX INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 078327 AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 076847 DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 077744 MYLAN
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 078284 ORCHID HLTHCARE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 078295 SUN PHARM INDS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 076554 SUN PHARM INDS LTD
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET;ORAL Prescription No AB 076933 WATSON LABS

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMITREX SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription Yes AB 020132 GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 200263 APOTEX INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 078327 AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 076847 DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 077744 MYLAN
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 078284 ORCHID HLTHCARE
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 078295 SUN PHARM INDS
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 076554 SUN PHARM INDS LTD
SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET;ORAL Prescription No AB 076933 WATSON LABS

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