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Last Updated: April 18, 2024

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. Eleven 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 Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 019627

Anesthetics, Intravenous
Hypnotics and Sedatives

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 (63323-269-45)
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 (63323-269-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Oct 2, 1989	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jun 11, 1996	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 1, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 019627

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Try a Trial	⤷ Try a Trial
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Try a Trial	⤷ Try a Trial
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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