Details for New Drug Application (NDA): 064096
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NDA 064096 describes AKTOB, which is a drug marketed by Epic Pharma Llc and is included in one NDA. It is available from one supplier. 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-six 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-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 064096
| Tradename: | AKTOB |
| Applicant: | Epic Pharma Llc |
| Ingredient: | tobramycin |
| Patents: | 0 |
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 | Proficient Rx LP | 63187-902 | 63187-902-02 | 1 BOTTLE, DROPPER in 1 CARTON (63187-902-02) / 2 mL in 1 BOTTLE, DROPPER |
| AKTOB | tobramycin | SOLUTION/DROPS;OPHTHALMIC | 064096 | ANDA | Proficient Rx LP | 63187-902 | 63187-902-05 | 1 BOTTLE, DROPPER in 1 CARTON (63187-902-05) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
| Approval Date: | Jan 31, 1996 | TE: | RLD: | No | |||||
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