Details for New Drug Application (NDA): 217722
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NDA 217722 describes RIVIVE, which is a drug marketed by Harm Reduction Therp and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the RIVIVE profile page.
The generic ingredient in RIVIVE is naloxone hydrochloride. There are twelve drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
The generic ingredient in RIVIVE is naloxone hydrochloride. There are twelve drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 217722
| Tradename: | RIVIVE |
| Applicant: | Harm Reduction Therp |
| Ingredient: | naloxone hydrochloride |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217722
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 217722
Suppliers and Packaging for NDA: 217722
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVIVE | naloxone hydrochloride | SPRAY, METERED;NASAL | 217722 | NDA | Harm Reduction Therapeutics, Inc. | 82954-0100 | 82954-0100-1 | 2 VIAL, SINGLE-DOSE in 1 CARTON (82954-0100-1) / .1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 3MG/SPRAY | ||||
| Approval Date: | Jul 28, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 11, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF INTRANASAL NALOXONE FOR THE TREATMENT OF OPIOID OVERDOSE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 11, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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