Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207457
Company: AUROBINDO PHARMA LTD

Products on ANDA 207457

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207457

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2020	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 207457

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	RISING
SUMATRIPTAN AND NAPROXEN SODIUM	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET;ORAL	Prescription	No	AB	202803	SUN PHARM
TREXIMET	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET;ORAL	Prescription	Yes	AB	021926	CURRAX