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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 050803

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NDA 050803 describes VELTIN, which is a drug marketed by Almirall and is included in one NDA. It is available from one supplier. Additional details are available on the VELTIN profile page.

The generic ingredient in VELTIN is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for 050803

Tradename:	VELTIN
Applicant:	Almirall
Ingredient:	clindamycin phosphate; tretinoin
Patents:	0

Suppliers and Packaging for NDA: 050803

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-959	66993-959-31	1 TUBE in 1 CARTON (66993-959-31) / 30 g in 1 TUBE
VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-959	66993-959-61	1 TUBE in 1 CARTON (66993-959-61) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	1.2%;0.025%
Approval Date:	Jul 16, 2010	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 050803

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803-001	Jul 16, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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