Details for New Drug Application (NDA): 208411
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NDA 208411 describes NARCAN, which is a drug marketed by Adapt, Bristol Myers Squibb, and Emergent, and is included in five NDAs. It is available from six suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NARCAN profile page.
The generic ingredient in NARCAN is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
The generic ingredient in NARCAN is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 208411
| Tradename: | NARCAN |
| Applicant: | Emergent |
| Ingredient: | naloxone hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 208411
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 208411
Suppliers and Packaging for NDA: 208411
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NARCAN | naloxone hydrochloride | SPRAY, METERED;NASAL | 208411 | NDA | A-S Medication Solutions | 50090-2422 | 50090-2422-0 | 2 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-2422-0) / .1 mL in 1 VIAL, SINGLE-DOSE |
| NARCAN | naloxone hydrochloride | SPRAY, METERED;NASAL | 208411 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-5908 | 50090-5908-0 | 2 VIAL, SINGLE-DOSE in 1 CARTON (50090-5908-0) / .1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 4MG/SPRAY | ||||
| Approval Date: | Nov 18, 2015 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 24, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 9,480,644 | Patent Expiration: | Mar 16, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
| Patented Use: | USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION. | ||||||||
| Patent: | 9,707,226 | Patent Expiration: | Mar 16, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
| Patented Use: | USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION. | ||||||||
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