Details for New Drug Application (NDA): 050108
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NDA 050108 describes COLY-MYCIN M, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. 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. Five suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.
The generic ingredient in COLY-MYCIN M is colistimethate sodium. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.
Summary for 050108
| Tradename: | COLY-MYCIN M |
| Applicant: | Endo Operations |
| Ingredient: | colistimethate sodium |
| Patents: | 0 |
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 | ENDO USA, 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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