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Details for New Drug Application (NDA): 050168

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NDA 050168 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: 050168

Pharmacology for NDA: 050168

Suppliers and Packaging for NDA: 050168

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate
OINTMENT;TOPICAL 050168 NDA Pfizer Laboratories Div Pfizer Inc 61570-031 61570-031-50 1 TUBE, WITH APPLICATOR in 1 CARTON (61570-031-50) > 14.2 g in 1 TUBE, WITH APPLICATOR

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM
Approval Date:May 4, 1984TE:RLD:Yes

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.