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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205067

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NDA 205067 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 205067

Tradename:	PROPOFOL
Applicant:	Dr Reddys
Ingredient:	propofol
Patents:	0

Pharmacology for NDA: 205067

Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 205067

Anesthetics, Intravenous
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 205067

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPOFOL	propofol	INJECTABLE;INJECTION	205067	ANDA	Dr. Reddy's Laboratories, Inc.	43598-265	43598-265-25	25 VIAL in 1 CARTON (43598-265-25) / 20 mL in 1 VIAL (43598-265-20)
PROPOFOL	propofol	INJECTABLE;INJECTION	205067	ANDA	Dr. Reddy's Laboratories, Inc.	43598-265	43598-265-58	10 VIAL in 1 CARTON (43598-265-58) / 20 mL in 1 VIAL (43598-265-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Nov 15, 2018	TE:	AB	RLD:	No

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