Details for New Drug Application (NDA): 205356
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NDA 205356 describes COLISTIMETHATE SODIUM, which is a drug marketed by Adrastea Pharma, Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, and Xellia Pharms Aps, and is included in six NDAs. It is available from four suppliers. Additional details are available on the COLISTIMETHATE SODIUM profile page.
The generic ingredient in COLISTIMETHATE SODIUM 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 COLISTIMETHATE SODIUM 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 205356
| Tradename: | COLISTIMETHATE SODIUM |
| Applicant: | Xellia Pharms Aps |
| Ingredient: | colistimethate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205356
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 205356 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-023 | 70594-023-09 | 1 VIAL in 1 CARTON (70594-023-09) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 205356 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-023 | 70594-023-01 | 1 VIAL, GLASS in 1 VIAL (70594-023-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 150MG BASE/VIAL | ||||
| Approval Date: | May 29, 2015 | TE: | AP | RLD: | No | ||||
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