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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 ten 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 fifty-seven suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.

Summary for NDA: 020353

Tradename:
NAPRELAN
Applicant:
Alvogen Malta
Ingredient:
naproxen sodium
Patents:0
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:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 500MG BASE
Approval Date:Jan 5, 1996TE:ABRLD:No

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

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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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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.

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