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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 074848

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NDA 074848 describes PROPOFOL, which is a drug marketed by Amneal, Aspiro, Avet Lifesciences, Dr Reddys, Hikma, Hospira, Innopharma, Sagent Pharms Inc, Teva Parenteral, and Watson Labs Inc, and is included in ten NDAs. It is available from eleven 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. Twelve suppliers are listed for this compound. Additional details are available on the propofol profile page.

Summary for 074848

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

Pharmacology for NDA: 074848

Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 074848

Anesthetics, Intravenous
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 074848

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPOFOL	propofol	INJECTABLE;INJECTION	074848	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6194	0641-6194-10	10 VIAL, SINGLE-USE in 1 CARTON (0641-6194-10) / 20 mL in 1 VIAL, SINGLE-USE (0641-6194-01)
PROPOFOL	propofol	INJECTABLE;INJECTION	074848	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6195	0641-6195-20	20 VIAL, SINGLE-USE in 1 CARTON (0641-6195-20) / 50 mL in 1 VIAL, SINGLE-USE (0641-6195-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Apr 19, 2005	TE:	AB	RLD:	No

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