Details for New Drug Application (NDA): 065372
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NDA 065372 describes POLYMYXIN B SULFATE, which is a drug marketed by Adrastea Pharma, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Rising, Xellia Pharms Aps, and Paddock Llc, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the POLYMYXIN B SULFATE profile page.
The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.
The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.
Summary for 065372
| Tradename: | POLYMYXIN B SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | polymyxin b sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065372
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 065372 | ANDA | Fresenius Kabi USA, LLC | 63323-321 | 63323-321-10 | 10 VIAL in 1 TRAY (63323-321-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-01) |
| POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 065372 | ANDA | Fresenius Kabi USA, LLC | 63323-321 | 63323-321-12 | 10 VIAL in 1 TRAY (63323-321-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500,000 UNITS BASE/VIAL | ||||
| Approval Date: | Jan 10, 2008 | TE: | AP | RLD: | No | ||||
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