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Details for New Drug Application (NDA): 050108

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NDA 050108 describes COLY-MYCIN M, which is a drug marketed by Par Sterile Products and is included in one NDA. It is available from two suppliers. Additional details are available on the COLY-MYCIN M profile page.

The generic ingredient in COLY-MYCIN M is colistimethate sodium. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.

Summary for NDA: 050108

Par Sterile Products
colistimethate sodium

Pharmacology for NDA: 050108


Suppliers and Packaging for NDA: 050108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
colistimethate sodium
INJECTABLE;INJECTION 050108 NDA Par Pharmaceutical Inc. 42023-107 42023-107-01 1 VIAL in 1 CARTON (42023-107-01) > 2 mL in 1 VIAL
colistimethate sodium
INJECTABLE;INJECTION 050108 NDA Par Pharmaceutical Inc. 42023-107 42023-107-06 6 VIAL in 1 CARTON (42023-107-06) > 2 mL in 1 VIAL

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD: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.