DrugPatentWatch Database Preview
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 nine 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. Twenty-five 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. Twenty-five 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 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 064096
| Ingredient-type | Aminoglycosides |
Medical Subject Heading (MeSH) Categories for 064096
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 | N | 0404-7196-01 |
| AKTOB | tobramycin | SOLUTION/DROPS;OPHTHALMIC | 064096 | ANDA | Blenheim Pharmacal, Inc. | 10544-883 | E | 10544-883-99 |
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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