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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 204652


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NDA 204652 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.
Summary for 204652
Tradename:FLUCYTOSINE
Applicant:Novel Labs Inc
Ingredient:flucytosine
Patents:0
Pharmacology for NDA: 204652
Medical Subject Heading (MeSH) Categories for 204652
Suppliers and Packaging for NDA: 204652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCYTOSINE flucytosine CAPSULE;ORAL 204652 ANDA Major Pharmaceuticals 0904-6834 0904-6834-07 30 BLISTER PACK in 1 CARTON (0904-6834-07) / 1 CAPSULE in 1 BLISTER PACK
FLUCYTOSINE flucytosine CAPSULE;ORAL 204652 ANDA Major Pharmaceuticals 0904-6835 0904-6835-07 30 BLISTER PACK in 1 CARTON (0904-6835-07) / 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jul 7, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Jul 7, 2017TE:ABRLD:No

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