Details for New Drug Application (NDA): 062196
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NDA 062196 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Cosette, 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, Epic Pharma Llc, Paco, Sandoz, B Braun, and Baxter Hlthcare, and is included in forty NDAs. It is available from nineteen suppliers. Additional details are available on the GENTAMICIN SULFATE profile page.
The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-two 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 are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062196
| Tradename: | GENTAMICIN SULFATE |
| Applicant: | Sandoz |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062196
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 062196 | ANDA | Sandoz Inc | 61314-633 | 61314-633-05 | 1 BOTTLE, DROPPER in 1 CARTON (61314-633-05) / 5 mL in 1 BOTTLE, DROPPER |
| GENTAMICIN SULFATE | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 062196 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-4775 | 68071-4775-5 | 5 mL in 1 BOTTLE (68071-4775-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.3% BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
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