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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021005

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NDA 021005 describes SOLARAZE, which is a drug marketed by Fougera Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the SOLARAZE profile page.

The generic ingredient in SOLARAZE is diclofenac sodium. There are forty-seven drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for NDA: 021005

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

Pharmacology for NDA: 021005

Suppliers and Packaging for NDA: 021005

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLARAZE
diclofenac sodium
GEL;TOPICAL 021005 NDA AUTHORIZED GENERIC E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0803 0168-0803-01 1 TUBE in 1 CARTON (0168-0803-01) > 100 g in 1 TUBE
SOLARAZE
diclofenac sodium
GEL;TOPICAL 021005 NDA AUTHORIZED GENERIC E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0844 0168-0844-01 1 TUBE in 1 CARTON (0168-0844-01) > 100 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength3%
Approval Date:Oct 16, 2000TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 021005

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,914,322► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,985,850► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,639,738► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,852,002► Subscribe
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,929,048► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Medtronic
UBS
Mallinckrodt
Colorcon
Deloitte
Dow
QuintilesIMS
US Department of Justice
McKinsey
AstraZeneca

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