Details for New Drug Application (NDA): 062196
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The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-six 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 |
Formulation / Manufacturing: | see details |
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 | 5 mL in 1 BOTTLE, PLASTIC (61314-633-05) |
GENTAMICIN SULFATE | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 062196 | ANDA | Preferred Pharmaceuticals Inc. | 68788-7336 | 68788-7336-5 | 5 mL in 1 BOTTLE, PLASTIC (68788-7336-5) |
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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