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Details for New Drug Application (NDA): 064096
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The generic ingredient in AKTOB is tobramycin. There are eighteen drug master file entries for this compound. Thirty 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 | MWI | 13985-604 | 13985-604-05 | 1 BOTTLE, DROPPER in 1 CARTON (13985-604-05) > 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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