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Generated: September 19, 2018

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Details for New Drug Application (NDA): 019968

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NDA 019968 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. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
Summary for 019968
Tradename:ULTRAVATE
Applicant:Sun Pharm Inds Inc
Ingredient:halobetasol propionate
Patents:0
Pharmacology for NDA: 019968
Suppliers and Packaging for NDA: 019968
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRAVATE halobetasol propionate OINTMENT;TOPICAL 019968 NDA Ranbaxy Laboratories Inc. 10631-102 10631-102-04 2 TUBE in 1 CARTON (10631-102-04) > 50 g in 1 TUBE
ULTRAVATE halobetasol propionate OINTMENT;TOPICAL 019968 NDA Ranbaxy Laboratories Inc. 10631-102 10631-102-50 1 TUBE in 1 CARTON (10631-102-50) > 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Dec 17, 1990TE:ABRLD:Yes

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