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Last Updated: November 2, 2024

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 ten 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. Eleven 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 EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 205067
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:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Nov 15, 2018TE:ABRLD:No

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