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Generated: March 23, 2019

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Details for New Drug Application (NDA): 090872

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NDA 090872 describes SUMATRIPTAN AND NAPROXEN SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Mylan Pharms Inc, and Sun Pharma Global, and is included in three NDAs. It is available from four suppliers. Additional details are available on the SUMATRIPTAN AND NAPROXEN SODIUM profile page.

The generic ingredient in SUMATRIPTAN AND NAPROXEN SODIUM is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.
Summary for 090872
Suppliers and Packaging for NDA: 090872
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 090872 ANDA Mylan Pharmaceuticals Inc. 0378-8755 0378-8755-59 9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8755-59)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 85MG BASE
Approval Date:Sep 4, 2018TE:ABRLD:No

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