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Generated: March 22, 2019

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Details for New Drug Application (NDA): 040879

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Summary for 040879
Applicant:Rising Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 040879
Medical Subject Heading (MeSH) Categories for 040879
Suppliers and Packaging for NDA: 040879
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 040879 ANDA Rising Pharmaceuticals, Inc. 64980-324 64980-324-30 1 TUBE in 1 CARTON (64980-324-30) > 30 g in 1 TUBE
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 040879 ANDA Preferred Pharmaceuticals, Inc. 68788-7091 68788-7091-3 1 TUBE in 1 CARTON (68788-7091-3) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%
Approval Date:Aug 20, 2010TE:ATRLD:No

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