Details for New Drug Application (NDA): 215041
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NDA 215041 describes RIFABUTIN, which is a drug marketed by Lupin Ltd and Novitium Pharma and is included in two NDAs. It is available from two 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. Four 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. Four 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 | Novitium Pharma LLC | 70954-041 | 70954-041-10 | 100 CAPSULE in 1 BOTTLE (70954-041-10) |
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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