Details for New Drug Application (NDA): 050108
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The generic ingredient in COLY-MYCIN M is colistimethate sodium. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.
Summary for 050108
Tradename: | COLY-MYCIN M |
Applicant: | Par Sterile Products |
Ingredient: | colistimethate sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 050108
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLY-MYCIN M | 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 |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 150MG BASE/VIAL | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
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