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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 019627


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NDA 019627 describes DIPRIVAN, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the DIPRIVAN profile page.

The generic ingredient in DIPRIVAN is propofol. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the propofol profile page.
Summary for 019627
Tradename:DIPRIVAN
Applicant:Fresenius Kabi Usa
Ingredient:propofol
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 019627
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 019627
Suppliers and Packaging for NDA: 019627
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPRIVAN propofol INJECTABLE;INJECTION 019627 NDA Fresenius Kabi USA, LLC 63323-269 63323-269-59 20 VIAL in 1 BOX (63323-269-59) > 50 mL in 1 VIAL
DIPRIVAN propofol INJECTABLE;INJECTION 019627 NDA Fresenius Kabi USA, LLC 63323-269 63323-269-69 10 VIAL in 1 BOX (63323-269-69) > 100 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Oct 2, 1989TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jun 11, 1996TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Jun 1, 2025Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 019627

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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