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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078595


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NDA 078595 describes FLUMAZENIL, which is a drug marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Rising, Sagent Pharms, and Sandoz, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the FLUMAZENIL profile page.

The generic ingredient in FLUMAZENIL is flumazenil. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the flumazenil profile page.
Summary for 078595
Tradename:FLUMAZENIL
Applicant:Rising
Ingredient:flumazenil
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078595

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5MG/5ML (0.1MG/ML)
Approval Date:May 13, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:May 13, 2008TE:RLD:No

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