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.
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 | Pfizer Laboratories Div Pfizer Inc | 0013-5301 | 0013-5301-17 | 100 CAPSULE in 1 BOTTLE (0013-5301-17) |
| MYCOBUTIN | rifabutin | CAPSULE;ORAL | 050689 | NDA AUTHORIZED GENERIC | Greenstone LLC | 59762-1350 | 59762-1350-1 | 100 CAPSULE in 1 BOTTLE (59762-1350-1) |
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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