Details for New Drug Application (NDA): 212045
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The generic ingredient in KLOXXADO 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 212045
Tradename: | KLOXXADO |
Applicant: | Hikma |
Ingredient: | naloxone hydrochloride |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212045
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 212045
Suppliers and Packaging for NDA: 212045
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KLOXXADO | naloxone hydrochloride | SPRAY;NASAL | 212045 | NDA | Hikma Specialty USA Inc. | 59467-679 | 59467-679-01 | .1 mL in 1 VIAL, SINGLE-DOSE (59467-679-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 8MG/SPRAY | ||||
Approval Date: | Apr 29, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 26, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 26, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 26, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? |
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