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Details for New Drug Application (NDA): 205307

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NDA 205307 describes PROPOFOL, which is a drug marketed by Sagent Pharms, Watson Labs Inc, Hospira, West-ward Pharms Int, and Teva Parenteral, 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. Eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the propofol profile page.

Summary for NDA: 205307

Watson Labs Inc

Pharmacology for NDA: 205307

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 205307

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 205307 ANDA Actavis Pharma, Inc. 0591-2136 0591-2136-51 20 VIAL in 1 CARTON (0591-2136-51) > 50 mL in 1 VIAL (0591-2136-55)
INJECTABLE;INJECTION 205307 ANDA Actavis Pharma, Inc. 0591-2136 0591-2136-68 10 VIAL in 1 CARTON (0591-2136-68) > 100 mL in 1 VIAL (0591-2136-57)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Dec 22, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Feb 24, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.