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Details for New Drug Application (NDA): 050218

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NDA 050218 describes CORTISPORIN, which is a drug marketed by Casper Pharma Llc and Monarch Pharms and is included in six NDAs. It is available from two suppliers. Additional details are available on the CORTISPORIN profile page.

The generic ingredient in CORTISPORIN is hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate. There are fifty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate profile page.

Summary for NDA: 050218

Tradename:
CORTISPORIN
Applicant:
Monarch Pharms
Ingredient:
hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050218

Suppliers and Packaging for NDA: 050218

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORTISPORIN
hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
CREAM;TOPICAL 050218 NDA Physicians Total Care, Inc. 54868-1531 54868-1531-1 1 TUBE in 1 CARTON (54868-1531-1) > 7.5 g in 1 TUBE
CORTISPORIN
hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
CREAM;TOPICAL 050218 NDA Pfizer Laboratories Div Pfizer Inc 61570-032 61570-032-75 1 TUBE in 1 CARTON (61570-032-75) > 7.5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:Aug 9, 1985TE:RLD:Yes


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