Last Updated: September 24, 2026

Details for New Drug Application (NDA): 077908

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NDA 077908 describes PROPOFOL, which is a drug marketed by Amneal, Anthea Pharma, Aspiro, Avet Lifesciences, Dr Reddys, Emerge Bioscience, Hikma, Hospira, Innopharma, Sagent Pharms Inc, Teva Parenteral, and Watson Labs Inc, and is included in twelve NDAs. It is available from thirteen suppliers. Additional details are available on the PROPOFOL profile page.

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

Summary for 077908

Tradename:	PROPOFOL
Applicant:	Hospira
Ingredient:	propofol
Patents:	0

Pharmacology for NDA: 077908

Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 077908

Anesthetics, Intravenous
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 077908

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPOFOL	propofol	INJECTABLE;INJECTION	077908	ANDA	Hospira, Inc.	0409-0010	0409-0010-98	10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0010-98) / 100 mL in 1 VIAL, SINGLE-DOSE (0409-0010-97)
PROPOFOL	propofol	INJECTABLE;INJECTION	077908	ANDA	Hospira, Inc.	0409-0501	0409-0501-98	20 VIAL, SINGLE-DOSE in 1 TRAY (0409-0501-98) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-0501-97)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Mar 17, 2006	TE:	AB	RLD:	No

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