Details for New Drug Application (NDA): 064054
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The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 064054
Tradename: | GENTAMICIN SULFATE |
Applicant: | Cosette |
Ingredient: | gentamicin sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 064054
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | gentamicin sulfate | OINTMENT;TOPICAL | 064054 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0682 | 0713-0682-15 | 1 TUBE in 1 CARTON (0713-0682-15) / 15 g in 1 TUBE |
GENTAMICIN SULFATE | gentamicin sulfate | OINTMENT;TOPICAL | 064054 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0682 | 0713-0682-31 | 1 TUBE in 1 CARTON (0713-0682-31) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | EQ 0.1% BASE | ||||
Approval Date: | Apr 29, 1994 | TE: | AT | RLD: | No |
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