Details for New Drug Application (NDA): 064093
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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 064093
Tradename: | GENTAMICIN SULFATE |
Applicant: | Akorn |
Ingredient: | gentamicin sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 064093
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | gentamicin sulfate | OINTMENT;OPHTHALMIC | 064093 | ANDA | Proficient Rx LP | 63187-873 | 63187-873-35 | 1 TUBE in 1 CARTON (63187-873-35) / 3.5 g in 1 TUBE |
GENTAMICIN SULFATE | gentamicin sulfate | OINTMENT;OPHTHALMIC | 064093 | ANDA | Redpharm Drug | 67296-0114 | 67296-0114-1 | 1 TUBE in 1 CARTON (67296-0114-1) / 3.5 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;OPHTHALMIC | Strength | EQ 0.3% BASE | ||||
Approval Date: | Aug 31, 1995 | TE: | RLD: | No |
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