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Generated: November 18, 2018

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Details for New Drug Application (NDA): 074222

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NDA 074222 describes EMBELINE, which is a drug marketed by Hi Tech Pharma and is included in four NDAs. It is available from four suppliers. Additional details are available on the EMBELINE profile page.

The generic ingredient in EMBELINE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 074222
Tradename:EMBELINE
Applicant:Hi Tech Pharma
Ingredient:clobetasol propionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074222
Medical Subject Heading (MeSH) Categories for 074222
Suppliers and Packaging for NDA: 074222
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMBELINE clobetasol propionate SOLUTION;TOPICAL 074222 ANDA Hi-Tech Pharmacal Co., Inc. 50383-266 50383-266-25 1 BOTTLE in 1 CARTON (50383-266-25) > 25 mL in 1 BOTTLE
EMBELINE clobetasol propionate SOLUTION;TOPICAL 074222 ANDA Hi-Tech Pharmacal Co., Inc. 50383-266 50383-266-50 1 BOTTLE in 1 CARTON (50383-266-50) > 50 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.05%
Approval Date:Dec 6, 1995TE:ATRLD:No

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