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Generated: January 19, 2019

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Details for New Drug Application (NDA): 020067

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NDA 020067 describes EC-NAPROSYN, which is a drug marketed by Atnahs Pharma Us and is included in one NDA. It is available from four suppliers. Additional details are available on the EC-NAPROSYN profile page.

The generic ingredient in EC-NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the naproxen profile page.
Summary for 020067
Tradename:EC-NAPROSYN
Applicant:Atnahs Pharma Us
Ingredient:naproxen
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020067
Medical Subject Heading (MeSH) Categories for 020067
Suppliers and Packaging for NDA: 020067
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EC-NAPROSYN naproxen TABLET, DELAYED RELEASE;ORAL 020067 NDA Genentech, Inc. 0004-6415 0004-6415-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0004-6415-01)
EC-NAPROSYN naproxen TABLET, DELAYED RELEASE;ORAL 020067 NDA Cameron Pharmaceuticals, LLC 42494-407 42494-407-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42494-407-01)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength375MG
Approval Date:Oct 14, 1994TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength500MG
Approval Date:Oct 14, 1994TE:ABRLD:Yes

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