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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076518

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NDA 076518 describes NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Inc and Perrigo and is included in two NDAs. It is available from twelve suppliers. Additional details are available on the NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 076518
Suppliers and Packaging for NDA: 076518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076518 ANDA L. Perrigo Company 0113-2417 N 0113-2417-01
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076518 ANDA Bayer HealthCare LLC. 0280-6045 N 0280-6045-10

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG BASE;120MG
Approval Date:Mar 17, 2004TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Teva
Healthtrust
Fish and Richardson
Covington
Julphar
Merck
Fuji
McKinsey

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