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Generated: November 15, 2018

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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. Nine 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
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:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Dec 27, 1990TE:ABRLD:Yes

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