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 one supplier. 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-three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
The generic ingredient in ZIMHI is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-three 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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