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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Farmers Insurance
Federal Trade Commission

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205307

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NDA 205307 describes PROPOFOL, which is a drug marketed by Hospira, Sagent Pharms, Teva Parenteral, Watson Labs Inc, and West-ward Pharms Int, and is included in five NDAs. It is available from four suppliers. Additional details are available on the PROPOFOL profile page.

The generic ingredient in PROPOFOL is propofol. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the propofol profile page.

Summary for 205307

Formulation / Manufacturing:see details

Pharmacology for NDA: 205307

Physiological EffectGeneral Anesthesia

Medical Subject Heading (MeSH) Categories for 205307

Suppliers and Packaging for NDA: 205307

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPOFOL propofol INJECTABLE;INJECTION 205307 ANDA Actavis Pharma, Inc. 0591-2136 0591-2136-51 20 VIAL in 1 CARTON (0591-2136-51) > 50 mL in 1 VIAL (0591-2136-55)
PROPOFOL propofol INJECTABLE;INJECTION 205307 ANDA Actavis Pharma, Inc. 0591-2136 0591-2136-68 10 VIAL in 1 CARTON (0591-2136-68) > 100 mL in 1 VIAL (0591-2136-57)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Dec 22, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Harvard Business School
Argus Health
Johnson and Johnson

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