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. 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. One hundred and twenty-seven 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 16, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021005

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,639,738	⤷ Get Started Free
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,929,048	⤷ Get Started Free
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,985,850	⤷ Get Started Free
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,914,322	⤷ Get Started Free
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000	5,792,753	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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