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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 204206


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NDA 204206 describes NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Mylan, and Sciegen Pharms Inc, and is included in five NDAs. It is available from three suppliers. Additional details are available on the NAPROXEN AND ESOMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.
Summary for 204206
Pharmacology for NDA: 204206
Suppliers and Packaging for NDA: 204206
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 204206 ANDA Dr. Reddy's Laboratories Limited 55111-289 55111-289-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 204206 ANDA Dr. Reddy's Laboratories Limited 55111-701 55111-701-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-701-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE;375MG
Approval Date:Feb 18, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE;500MG
Approval Date:Feb 18, 2020TE:ABRLD:No

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