Details for New Drug Application (NDA): 205787
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The generic ingredient in EVZIO 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 205787
Tradename: | EVZIO |
Applicant: | Kaleo Inc |
Ingredient: | naloxone hydrochloride |
Patents: | 33 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 205787
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 0.4MG/0.4ML (0.4MG/0.4ML) | ||||
Approval Date: | Apr 3, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 24, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 20, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
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