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Generated: October 19, 2017

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 Perrigo and Dr Reddys Labs Inc and is included in two NDAs. It is available from fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

Summary for NDA: 076518

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

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 0113-2417-01 20 BLISTER PACK in 1 CARTON (0113-2417-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
naproxen sodium; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 076518 ANDA Bayer HealthCare LLC. 0280-6045 0280-6045-10 1 BLISTER PACK in 1 CARTON (0280-6045-10) > 10 TABLET in 1 BLISTER PACK

Summary 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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