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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 three suppliers. There are five patents 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. Eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the propofol profile page.

Summary for NDA: 019627

Tradename:
DIPRIVAN
Applicant:
Fresenius Kabi Usa
Ingredient:
propofol
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 019627

Physiological EffectGeneral Anesthesia

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 General Injectables & Vaccines, Inc 52584-269 52584-269-50 1 VIAL in 1 BAG (52584-269-50) > 50 mL in 1 VIAL
DIPRIVAN
propofol
INJECTABLE;INJECTION 019627 NDA Fresenius Kabi USA, LLC 63323-269 63323-269-37 10 VIAL in 1 BOX (63323-269-37) > 20 mL in 1 VIAL

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jun 11, 1996TE:ABRLD:Yes
Patent:5,714,520*PEDPatent Expiration:Sep 22, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,731,355*PEDPatent Expiration:Sep 22, 2015Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 019627

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa
DIPRIVAN
propofol
INJECTABLE;INJECTION019627-002Jun 11, 19965,714,520*PED► subscribe
Fresenius Kabi Usa
DIPRIVAN
propofol
INJECTABLE;INJECTION019627-002Jun 11, 19965,908,869*PED► subscribe
Fresenius Kabi Usa
DIPRIVAN
propofol
INJECTABLE;INJECTION019627-002Jun 11, 19965,731,356*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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