Details for New Drug Application (NDA): 205787
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NDA 205787 describes EVZIO, which is a drug marketed by Kaleo Inc and is included in two NDAs. There are thirty-four patents protecting this drug. Additional details are available on the EVZIO profile page.
The generic ingredient in EVZIO 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.
The generic ingredient in EVZIO 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 205787
| Tradename: | EVZIO |
| Applicant: | Kaleo Inc |
| Ingredient: | naloxone hydrochloride |
| Patents: | 33 |
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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Nov 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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