Details for New Drug Application (NDA): 205604
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NDA 205604 describes AMIKACIN SULFATE, which is a drug marketed by Abbott, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, Qilu, and Sagent Pharms Inc, and is included in twenty-one NDAs. It is available from five suppliers. Additional details are available on the AMIKACIN SULFATE profile page.
The generic ingredient in AMIKACIN SULFATE is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
The generic ingredient in AMIKACIN SULFATE is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
Summary for 205604
| Tradename: | AMIKACIN SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | amikacin sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205604
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 205604 | ANDA | Fresenius Kabi USA, LLC | 63323-815 | 63323-815-02 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21) |
| AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 205604 | ANDA | Fresenius Kabi USA, LLC | 63323-815 | 63323-815-04 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/ML | ||||
| Approval Date: | Dec 9, 2015 | TE: | AP | RLD: | No | ||||
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