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Last Updated: June 9, 2023

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 three 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. Fifty-six suppliers are listed for this compound. Additional details are available on the naproxen profile page.
Summary for 020067
Applicant:Atnahs Pharma Us
Formulation / Manufacturing:see details
Pharmacology for NDA: 020067
Mechanism of ActionCyclooxygenase Inhibitors
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 Bryant Ranch Prepack 63629-2484 63629-2484-1 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63629-2484-1)
EC-NAPROSYN naproxen TABLET, DELAYED RELEASE;ORAL 020067 NDA Canton Laboratories 69437-415 69437-415-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69437-415-01)

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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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Johnson and Johnson

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