Details for New Drug Application (NDA): 215041
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NDA 215041 describes RIFABUTIN, which is a drug marketed by I3 Pharms, Lupin, and Novitium Pharma, and is included in three NDAs. It is available from five 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the rifabutin profile page.
Summary for 215041
| Tradename: | RIFABUTIN |
| Applicant: | Novitium Pharma |
| Ingredient: | rifabutin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215041
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIFABUTIN | rifabutin | CAPSULE;ORAL | 215041 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-738 | 10135-738-01 | 100 CAPSULE in 1 BOTTLE (10135-738-01) |
| RIFABUTIN | rifabutin | CAPSULE;ORAL | 215041 | ANDA | REMEDYREPACK INC. | 70518-4594 | 70518-4594-0 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4594-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Dec 17, 2021 | TE: | AB | RLD: | No | ||||
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