Details for New Drug Application (NDA): 212854
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The generic ingredient in ZIMHI is naloxone hydrochloride. There are twelve drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 212854
Tradename: | ZIMHI |
Applicant: | Adamis Pharms Corp |
Ingredient: | naloxone hydrochloride |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212854
Mechanism of Action | Opioid 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 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 5MG/0.5ML (5MG/0.5ML) | ||||
Approval Date: | Oct 15, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 24, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 14, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF AN OPIOID ANTAGONIST COMPRISING AN EMERGENCY SYRINGE DEVICE | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 14, 2041 | Product Flag? | Y | Substance 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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