Details for New Drug Application (NDA): 212045
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NDA 212045 describes KLOXXADO, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the KLOXXADO profile page.
The generic ingredient in KLOXXADO is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
The generic ingredient in KLOXXADO is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-three 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 |
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 | |||||
| Regulatory Exclusivity Expiration: | Apr 29, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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 | ||||||||
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