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Details for New Drug Application (NDA): 204040
NDA 204040 describes AMIKACIN SULFATE, which is a drug marketed by Abbott, Emcure Pharms Ltd, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Sagent Pharms, Teva Pharms Usa, and West-ward Pharms Int, and is included in twenty 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 204040
| Tradename: | AMIKACIN SULFATE |
| Applicant: | Emcure Pharms Ltd |
| Ingredient: | amikacin sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204040
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 204040 | ANDA | Heritage Pharmaceuticals Inc. | 23155-290 | 23155-290-41 | 10 VIAL, GLASS in 1 CARTON (23155-290-41) > 2 mL in 1 VIAL, GLASS (23155-290-31) |
| AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 204040 | ANDA | Heritage Pharmaceuticals Inc. | 23155-290 | 23155-290-42 | 10 VIAL, GLASS in 1 CARTON (23155-290-42) > 4 mL in 1 VIAL, GLASS (23155-290-32) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/ML | ||||
| Approval Date: | Dec 12, 2013 | TE: | AP | RLD: | No | ||||
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