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Generated: November 20, 2018

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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 five 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 suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.
Summary for 020353
Tradename:NAPRELAN
Applicant:Alvogen Malta
Ingredient:naproxen sodium
Patents:0
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 Rebel Distributors Corp 21695-905 21695-905-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-905-60)
NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353 NDA Rebel Distributors Corp 21695-906 21695-906-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-906-60)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 020353

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996 ➤ Sign Up ➤ Sign Up
Alvogen Malta NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-003 Jan 5, 1996 ➤ Sign Up ➤ Sign Up
Alvogen Malta NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-002 Jan 5, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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