Details for New Drug Application (NDA): 215487
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The generic ingredient in REZENOPY 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 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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