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Details for New Drug Application (NDA): 064048
NDA 064048 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Perrigo New York, Pharmaderm, Taro, Abbott, Fresenius Kabi Usa, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Akorn, Perrigo Co Tennessee, Alcon Pharms Ltd, Bausch And Lomb, Paco, Sandoz Inc, B Braun, and Baxter Hlthcare, and is included in thirty-seven 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 are fifteen drug master file entries for this compound. Thirty 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. Thirty suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 064048
| Tradename: | GENTAMICIN SULFATE |
| Applicant: | Bausch And Lomb |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 064048
| Ingredient-type | Aminoglycosides |
Suppliers and Packaging for NDA: 064048
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 064048 | ANDA | Bausch & Lomb Incorporated | 24208-580 | N | 24208-580-64 |
| GENTAMICIN SULFATE | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 064048 | ANDA | Bausch & Lomb Incorporated | 24208-580 | N | 24208-580-60 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.3% BASE | ||||
| Approval Date: | May 11, 1994 | TE: | AT | RLD: | No | ||||
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