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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 205576


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NDA 205576 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 205576
Tradename:PROPOFOL
Applicant:Innopharma
Ingredient:propofol
Patents:0
Pharmacology for NDA: 205576
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 205576
Suppliers and Packaging for NDA: 205576
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPOFOL propofol INJECTABLE;INJECTION 205576 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0209 0069-0209-10 10 VIAL in 1 CARTON (0069-0209-10) / 20 mL in 1 VIAL (0069-0209-01)
PROPOFOL propofol INJECTABLE;INJECTION 205576 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0234 0069-0234-20 20 VIAL in 1 CARTON (0069-0234-20) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Sep 16, 2020TE:ABRLD:No

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