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Federal Trade Commission
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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205307

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NDA 205307 describes PROPOFOL, which is a drug marketed by Hospira, Sagent Pharms, Teva Parenteral, Watson Labs Inc, and West-ward Pharms Int, and is included in five NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the propofol profile page.
Summary for 205307
Applicant:Watson Labs Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 205307
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 205307
Suppliers and Packaging for NDA: 205307
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPOFOL propofol INJECTABLE;INJECTION 205307 ANDA Actavis Pharma, Inc. 0591-2136 N 0591-2136-51
PROPOFOL propofol INJECTABLE;INJECTION 205307 ANDA Actavis Pharma, Inc. 0591-2136 N 0591-2136-68

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Dec 22, 2015TE:ABRLD:No

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