Details for New Drug Application (NDA): 062351
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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 062351
Tradename: | GENTAMICIN SULFATE |
Applicant: | Padagis Us |
Ingredient: | gentamicin sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 062351
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | gentamicin sulfate | OINTMENT;TOPICAL | 062351 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-046 | 45802-046-11 | 1 TUBE in 1 CARTON (45802-046-11) / 30 g in 1 TUBE |
GENTAMICIN SULFATE | gentamicin sulfate | OINTMENT;TOPICAL | 062351 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-046 | 45802-046-35 | 1 TUBE in 1 CARTON (45802-046-35) / 15 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | EQ 0.1% BASE | ||||
Approval Date: | Feb 18, 1982 | TE: | AT | RLD: | No |
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