Details for New Drug Application (NDA): 201566
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NDA 201566 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 201566
| Tradename: | FLUCYTOSINE |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | flucytosine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201566
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 201566 | ANDA | Sigmapharm Laboratories, LLC | 42794-009 | 42794-009-08 | 30 CAPSULE in 1 BOTTLE (42794-009-08) |
| FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 201566 | ANDA | Sigmapharm Laboratories, LLC | 42794-010 | 42794-010-08 | 30 CAPSULE in 1 BOTTLE (42794-010-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Jun 28, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Jun 28, 2011 | TE: | AB | RLD: | No | ||||
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