Details for New Drug Application (NDA): 215457
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NDA 215457 describes NALOXONE HYDROCHLORIDE (AUTOINJECTOR), which is a drug marketed by Kaleo Inc and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the NALOXONE HYDROCHLORIDE (AUTOINJECTOR) profile page.
The generic ingredient in NALOXONE HYDROCHLORIDE (AUTOINJECTOR) 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.
The generic ingredient in NALOXONE HYDROCHLORIDE (AUTOINJECTOR) 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 215457
| Tradename: | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) |
| Applicant: | Kaleo Inc |
| Ingredient: | naloxone hydrochloride |
| Patents: | 18 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215457
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 215457
Suppliers and Packaging for NDA: 215457
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 215457 | NDA | Kaleo, Inc. | 60842-002 | 60842-002-02 | 10 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 10MG/0.4ML (10MG/0.4ML) | ||||
| Approval Date: | Feb 28, 2022 | 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: | Nov 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a 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 | ||||||||
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