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Details for New Drug Application (NDA): 018164

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NDA 018164 describes ANAPROX DS, 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 ANAPROX DS profile page.

The generic ingredient in ANAPROX DS is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and sixty-one suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.

Summary for NDA: 018164

Atnahs Pharma Us
naproxen sodium
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018164

Suppliers and Packaging for NDA: 018164

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naproxen sodium
TABLET;ORAL 018164 NDA Genentech, Inc. 0004-6203 0004-6203-01 100 TABLET in 1 BOTTLE, PLASTIC (0004-6203-01)
naproxen sodium
TABLET;ORAL 018164 NDA Cameron Pharmaceuticals, LLC 42494-400 42494-400-01 100 TABLET in 1 BOTTLE, PLASTIC (42494-400-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Sep 30, 1987TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018164

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us
naproxen sodium
TABLET;ORAL018164-001Approved Prior to Jan 1, 19823,998,966► subscribe
Atnahs Pharma Us
naproxen sodium
TABLET;ORAL018164-003Sep 30, 19873,998,966► subscribe
Atnahs Pharma Us
naproxen sodium
TABLET;ORAL018164-003Sep 30, 19874,001,301► subscribe
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