Details for New Drug Application (NDA): 212430
NDA 212430 describes RIFABUTIN, which is a drug marketed by Lupin, Novitium Pharma, Pharmazone, and Zydus Lifesciences, and is included in four NDAs. It is available from four suppliers. Additional details are available on the RIFABUTIN profile page.
The generic ingredient in RIFABUTIN is rifabutin. There is one drug master file entry 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 is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the rifabutin profile page.
Summary for 212430
| Tradename: | RIFABUTIN |
| Applicant: | Pharmazone |
| Ingredient: | rifabutin |
| Patents: | 0 |
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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