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. Fifty 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: | 21 |
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: | ⤷ Start 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: | ⤷ Start 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: | ⤷ Start Trial | Patent Expiration: | Feb 28, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE | ||||||||
Expired US Patents for NDA 205787
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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