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. Forty-four 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 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: | ⤷ Sign Up | Patent Expiration: | May 24, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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