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 twenty-five 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-eight 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-eight 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: | 24 |
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: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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