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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212632


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NDA 212632 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 212632
Tradename:FLUCYTOSINE
Applicant:Strides Pharma
Ingredient:flucytosine
Patents:0
Pharmacology for NDA: 212632
Medical Subject Heading (MeSH) Categories for 212632
Suppliers and Packaging for NDA: 212632
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCYTOSINE flucytosine CAPSULE;ORAL 212632 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-860 23155-860-01 100 CAPSULE in 1 BOTTLE (23155-860-01)
FLUCYTOSINE flucytosine CAPSULE;ORAL 212632 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-860 23155-860-03 30 CAPSULE in 1 BOTTLE (23155-860-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Apr 17, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Apr 17, 2020TE:ABRLD:No

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