Details for New Drug Application (NDA): 050689
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NDA 050689 describes MYCOBUTIN, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. Additional details are available on the MYCOBUTIN profile page.
The generic ingredient in MYCOBUTIN 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 MYCOBUTIN 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.
Medical Subject Heading (MeSH) Categories for 050689
Suppliers and Packaging for NDA: 050689
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCOBUTIN | rifabutin | CAPSULE;ORAL | 050689 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-1350 | 59762-1350-1 | 100 CAPSULE in 1 BOTTLE (59762-1350-1) |
| MYCOBUTIN | rifabutin | CAPSULE;ORAL | 050689 | NDA AUTHORIZED GENERIC | REMEDYREPACK INC. | 70518-4254 | 70518-4254-0 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Dec 23, 1992 | TE: | AB | RLD: | Yes | ||||
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