Details for New Drug Application (NDA): 019967

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NDA 019967 describes ULTRAVATE, which is a drug marketed by Sun Pharm Inds Inc and Sun Pharm Industries and is included in three NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ULTRAVATE profile page.

The generic ingredient in ULTRAVATE is halobetasol propionate. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

Summary for 019967

Tradename:	ULTRAVATE
Applicant:	Sun Pharm Inds Inc
Ingredient:	halobetasol propionate
Patents:	0

Pharmacology for NDA: 019967

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 019967

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967	NDA	Ranbaxy Laboratories Inc.	10631-103	10631-103-04	2 TUBE in 1 CARTON (10631-103-04) > 50 g in 1 TUBE
ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967	NDA	Ranbaxy Laboratories Inc.	10631-103	10631-103-50	1 TUBE in 1 CARTON (10631-103-50) > 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Dec 27, 1990	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019967

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967-001	Dec 27, 1990	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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