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Last Updated: April 15, 2024

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 two 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 thirty-five suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.
Summary for 018164
Tradename:ANAPROX DS
Applicant:Atnahs Pharma Us
Ingredient:naproxen sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018164
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 018164
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANAPROX naproxen sodium TABLET;ORAL 018164 NDA Canton Laboratories 69437-203 69437-203-01 100 TABLET in 1 BOTTLE, PLASTIC (69437-203-01)
ANAPROX naproxen sodium TABLET;ORAL 018164 NDA Woodward Pharma Services LLC 69784-550 69784-550-01 100 TABLET in 1 BOTTLE, PLASTIC (69784-550-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

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

Expired US Patents for NDA 018164

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us ANAPROX naproxen sodium TABLET;ORAL 018164-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ⤷  Try a Trial ⤷  Try a Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ⤷  Try a Trial ⤷  Try a Trial
Atnahs Pharma Us ANAPROX naproxen sodium TABLET;ORAL 018164-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ⤷  Try a Trial ⤷  Try a Trial
Atnahs Pharma Us ANAPROX naproxen sodium TABLET;ORAL 018164-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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