Details for New Drug Application (NDA): 062251
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NDA 062251 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Cosette Pharms Nc, Fougera Pharms Inc, Padagis Us, Pharmaderm, Sun Pharma Canada, Abbott, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, Wyeth Ayerst, Fera Pharms Llc, Sciegen Pharms, Encube, Alcon Pharms Ltd, Bausch And Lomb Inc, Epic Pharma Llc, Paco, Sandoz, B Braun, and Baxter Hlthcare, and is included in forty NDAs. It is available from twenty suppliers. Additional details are available on the GENTAMICIN SULFATE profile page.
The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062251
| Tradename: | GENTAMICIN SULFATE |
| Applicant: | Hikma |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062251
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | gentamicin sulfate | INJECTABLE;INJECTION | 062251 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9128 | 0143-9128-25 | 25 VIAL in 1 CARTON (0143-9128-25) / 2 mL in 1 VIAL (0143-9128-01) |
| GENTAMICIN SULFATE | gentamicin sulfate | INJECTABLE;INJECTION | 062251 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9129 | 0143-9129-10 | 10 VIAL in 1 CARTON (0143-9129-10) / 20 mL in 1 VIAL (0143-9129-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
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