Details for New Drug Application (NDA): 213665
✉ Email this page to a colleague
NDA 213665 describes FLUCYTOSINE, which is a drug marketed by Aurobindo Pharma Ltd, Hikma, Novel Labs Inc, Sigmapharm Labs Llc, and Strides Pharma, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the FLUCYTOSINE profile page.
The generic ingredient in FLUCYTOSINE 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 FLUCYTOSINE 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 213665
| Tradename: | FLUCYTOSINE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | flucytosine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213665
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 213665 | ANDA | Aurobindo Pharma Limited | 59651-331 | 59651-331-01 | 100 CAPSULE in 1 BOTTLE (59651-331-01) |
| FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 213665 | ANDA | Aurobindo Pharma Limited | 59651-332 | 59651-332-01 | 100 CAPSULE in 1 BOTTLE (59651-332-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | May 1, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | May 1, 2020 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
