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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050356

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NDA 050356 describes COLY-MYCIN S, which is a drug marketed by Endo Pharms Inc and Parke Davis and is included in two NDAs. It is available from two suppliers. Additional details are available on the COLY-MYCIN S profile page.

The generic ingredient in COLY-MYCIN S is colistin sulfate. There are four drug master file entries for this compound. Additional details are available on the colistin sulfate profile page.
Pharmacology for NDA: 050356
Suppliers and Packaging for NDA: 050356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLY-MYCIN S colistin sulfate; hydrocortisone acetate; neomycin sulfate; thonzonium bromide SUSPENSION/DROPS;OTIC 050356 NDA Endo Pharmaceuticals Inc. 63481-421 63481-421-05 10 mL in 1 BOTTLE, DROPPER (63481-421-05)
COLY-MYCIN S colistin sulfate; hydrocortisone acetate; neomycin sulfate; thonzonium bromide SUSPENSION/DROPS;OTIC 050356 NDA Endo Pharmaceuticals, Inc. 63481-529 63481-529-10 10 mL in 1 BOTTLE, DROPPER (63481-529-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrengthEQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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