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Details for New Drug Application (NDA): 064096
NDA 064096 describes AKTOB, which is a drug marketed by Akorn and is included in one NDA. It is available from ten suppliers. Additional details are available on the AKTOB profile page.
The generic ingredient in AKTOB is tobramycin. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
The generic ingredient in AKTOB is tobramycin. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 064096
| Tradename: | AKTOB |
| Applicant: | Akorn |
| Ingredient: | tobramycin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 064096
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AKTOB | tobramycin | SOLUTION/DROPS;OPHTHALMIC | 064096 | ANDA | Henry Schein Inc. | 0404-7196 | 0404-7196-01 | 1 BOTTLE, DROPPER in 1 CARTON (0404-7196-01) > 5 mL in 1 BOTTLE, DROPPER |
| AKTOB | tobramycin | SOLUTION/DROPS;OPHTHALMIC | 064096 | ANDA | Blenheim Pharmacal, Inc. | 10544-883 | 10544-883-99 | 1 BOTTLE, DROPPER in 1 CARTON (10544-883-99) > 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
| Approval Date: | Jan 31, 1996 | TE: | AT | RLD: | No | ||||
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