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Details for New Drug Application (NDA): 205787

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NDA 205787 describes EVZIO, which is a drug marketed by Kaleo Inc and is included in two NDAs. It is available from one supplier. There are twenty-three patents protecting this drug. Additional details are available on the EVZIO profile page.

The generic ingredient in EVZIO is naloxone hydrochloride. There are twelve drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

Summary for NDA: 205787

Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205787

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 205787

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787 NDA kaleo, Inc. 60842-030 60842-030-01 2 INJECTION, SOLUTION in 1 CARTON (60842-030-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrength0.4MG/0.4ML (0.4MG/0.4ML)
Approval Date:Apr 3, 2014TE:RLD:Yes
Patent:7,731,686Patent Expiration:Jun 10, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:7,731,690Patent Expiration:Jan 15, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,749,194Patent Expiration:Oct 30, 2028Product Flag?YSubstance Flag?Delist Request?

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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.