Details for New Drug Application (NDA): 215457
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The generic ingredient in NALOXONE HYDROCHLORIDE (AUTOINJECTOR) 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 215457
Tradename: | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) |
Applicant: | Kaleo Inc |
Ingredient: | naloxone hydrochloride |
Patents: | 18 |
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: | ⤷ 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: | Nov 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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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