Details for New Drug Application (NDA): 017001
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NDA 017001 describes ANCOBON, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. Additional details are available on the ANCOBON profile page.
The generic ingredient in ANCOBON is flucytosine. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the flucytosine profile page.
The generic ingredient in ANCOBON is flucytosine. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the flucytosine profile page.
Summary for 017001
| Tradename: | ANCOBON |
| Applicant: | Bausch |
| Ingredient: | flucytosine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017001
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANCOBON | flucytosine | CAPSULE;ORAL | 017001 | NDA | Bausch Health US LLC | 0187-3554 | 0187-3554-10 | 100 CAPSULE in 1 BOTTLE (0187-3554-10) |
| ANCOBON | flucytosine | CAPSULE;ORAL | 017001 | NDA | Bausch Health US LLC | 0187-3555 | 0187-3555-10 | 100 CAPSULE in 1 BOTTLE (0187-3555-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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