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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 212854


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NDA 212854 describes ZIMHI, which is a drug marketed by Zmi Pharma and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the ZIMHI profile page.

The generic ingredient in ZIMHI is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 212854
Tradename:ZIMHI
Applicant:Zmi Pharma
Ingredient:naloxone hydrochloride
Patents:2
Pharmacology for NDA: 212854
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 212854
Suppliers and Packaging for NDA: 212854
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIMHI naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 212854 NDA USWM, LLC 78670-140 78670-140-02 2 CASE in 1 CARTON (78670-140-02) / 1 SYRINGE in 1 CASE (78670-140-11) / .5 mL in 1 SYRINGE
ZIMHI naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 212854 NDA ZMI Pharma Inc. 84571-140 84571-140-02 2 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrength5MG/0.5ML (5MG/0.5ML)
Approval Date:Oct 15, 2021TE:RLD:Yes
Patent:⤷  SubscribePatent Expiration:May 24, 2039Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  SubscribePatent Expiration:Jun 14, 2041Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF AN OPIOID ANTAGONIST COMPRISING AN EMERGENCY SYRINGE DEVICE
Patent:⤷  SubscribePatent Expiration:Jun 14, 2041Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF AN OPIOID ANTAGONIST COMPRISING AN EMERGENCY SYRINGE DEVICE INCLUDING A NEEDLE GUARD

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