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

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Mallinckrodt
Baxter
AstraZeneca
McKinsey

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018164

See Plans and Pricing

« Back to Dashboard

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Moodys
McKesson
Colorcon
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.