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Generated: January 23, 2019

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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 fifty-nine 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
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 Cameron Pharmaceuticals, LLC 42494-400 42494-400-01 100 TABLET in 1 BOTTLE, PLASTIC (42494-400-01)
ANAPROX naproxen sodium TABLET;ORAL 018164 NDA Cameron Pharmaceuticals, LLC 42494-400 42494-400-05 500 TABLET in 1 BOTTLE, PLASTIC (42494-400-05)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 250MG BASE
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 Free Trial ➤ Try a Free Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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