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

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Last Updated: November 18, 2019

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. Seventy-eight suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 021005
Tradename:SOLARAZE
Applicant:Fougera Pharms
Ingredient:diclofenac sodium
Patents:0
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
Paragraph IV (Patent) Challenges for 021005
Tradename Dosage Ingredient NDA Submissiondate
SOLARAZE GEL;TOPICAL diclofenac sodium 021005 2009-12-16

Profile for product number 001

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

Expired US Patents for NDA 021005

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000   Start Trial   Start Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000   Start Trial   Start Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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