Details for New Drug Application (NDA): 215487
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NDA 215487 describes REZENOPY, which is a drug marketed by Summit Biosci and is included in one NDA. It is available from one supplier. Additional details are available on the REZENOPY profile page.
The generic ingredient in REZENOPY 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 REZENOPY 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 215487
| Tradename: | REZENOPY |
| Applicant: | Summit Biosci |
| Ingredient: | naloxone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215487
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 215487
Suppliers and Packaging for NDA: 215487
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REZENOPY | naloxone hydrochloride | SPRAY;NASAL | 215487 | NDA | Summit Biosciences Inc. | 43674-003 | 43674-003-02 | 2 BLISTER PACK in 1 CARTON (43674-003-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 10MG/SPRAY | ||||
| Approval Date: | Apr 19, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 19, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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