Details for New Drug Application (NDA): 063315
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NDA 063315 describes AMIKACIN SULFATE, which is a drug marketed by Abbott, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, and Sagent Pharms Inc, and is included in twenty NDAs. It is available from four 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
Summary for 063315
| Tradename: | AMIKACIN SULFATE |
| Applicant: | Hikma |
| Ingredient: | amikacin sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 063315
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063315 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6166 | 0641-6166-10 | 10 VIAL in 1 CARTON (0641-6166-10) / 4 mL in 1 VIAL (0641-6166-01) |
| AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063315 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6167 | 0641-6167-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6167-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6167-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/ML | ||||
| Approval Date: | Apr 11, 1994 | TE: | AP | RLD: | No | ||||
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