Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207457
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUMATRIPTAN AND NAPROXEN SODIUM NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500MG;EQ 85MG 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
02/15/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207457Orig1s000ltr.pdf

SUMATRIPTAN AND NAPROXEN SODIUM

TABLET;ORAL; 500MG;EQ 85MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SUMATRIPTAN AND NAPROXEN SODIUM NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500MG;EQ 85MG BASE TABLET;ORAL Prescription No AB 207457 AUROBINDO PHARMA LTD
SUMATRIPTAN AND NAPROXEN SODIUM NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500MG;EQ 85MG BASE TABLET;ORAL Prescription No AB 090872 MYLAN PHARMS INC
SUMATRIPTAN AND NAPROXEN SODIUM NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500MG;EQ 85MG BASE TABLET;ORAL Prescription No AB 202803 SUN PHARMA GLOBAL
TREXIMET NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500MG;EQ 85MG BASE TABLET;ORAL Prescription Yes AB 021926 PERNIX IRELAND LTD

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