Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017581

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NDA 017581 describes NAPROSYN, which is a drug marketed by Atnahs Pharma Us and is included in two NDAs. It is available from five suppliers. Additional details are available on the NAPROSYN profile page.

The generic ingredient in NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the naproxen profile page.
Summary for 017581
Tradename:NAPROSYN
Applicant:Atnahs Pharma Us
Ingredient:naproxen
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017581
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 017581
Suppliers and Packaging for NDA: 017581
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROSYN naproxen TABLET;ORAL 017581 NDA Canton Laboratories 69437-316 69437-316-01 100 TABLET in 1 BOTTLE, PLASTIC (69437-316-01)
NAPROSYN naproxen TABLET;ORAL 017581 NDA Woodward Pharma Services LLC 69784-505 69784-505-01 100 TABLET in 1 BOTTLE, PLASTIC (69784-505-01)

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength375MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 15, 1982TE:ABRLD:Yes

Expired US Patents for NDA 017581

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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