Details for New Drug Application (NDA): 212430
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NDA 212430 describes RIFABUTIN, which is a drug marketed by I3 Pharms, Lupin Ltd, and Novitium Pharma, and is included in three NDAs. It is available from four suppliers. Additional details are available on the RIFABUTIN profile page.
The generic ingredient in RIFABUTIN is rifabutin. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the rifabutin profile page.
The generic ingredient in RIFABUTIN is rifabutin. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the rifabutin profile page.
Suppliers and Packaging for NDA: 212430
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIFABUTIN | rifabutin | CAPSULE;ORAL | 212430 | ANDA | i3 Pharmaceuticals, LLC | 72319-010 | 72319-010-04 | 100 CAPSULE in 1 BOTTLE (72319-010-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Mar 19, 2026 | TE: | AB | RLD: | No | ||||
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