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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020353

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NDA 020353 describes NAPRELAN, which is a drug marketed by Alvogen Malta and is included in one NDA. It is available from seven suppliers. Additional details are available on the NAPRELAN profile page.

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

Summary for NDA: 020353

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020353

Suppliers and Packaging for NDA: 020353

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL 020353 NDA STAT RX USA 16590-242 16590-242-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-242-30)
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL 020353 NDA Rebel Distributors Corp 21695-905 21695-905-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-905-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 375MG BASE
Approval Date:Jan 5, 1996TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 500MG BASE
Approval Date:Jan 5, 1996TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 750MG BASE
Approval Date:Jan 5, 1996TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020353

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-001Jan 5, 19965,637,320► Subscribe
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-003Jan 5, 19965,637,320► Subscribe
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-002Jan 5, 19965,637,320► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Julphar
Chubb
Healthtrust
Deloitte
Farmers Insurance
Fuji
Citi
Baxter
AstraZeneca
Accenture

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