Details for New Drug Application (NDA): 208969
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NDA 208969 describes REXTOVY, which is a drug marketed by Amphastar Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the REXTOVY profile page.
The generic ingredient in REXTOVY is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
The generic ingredient in REXTOVY is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 208969
| Tradename: | REXTOVY |
| Applicant: | Amphastar Pharms Inc |
| Ingredient: | naloxone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208969
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 208969
Suppliers and Packaging for NDA: 208969
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REXTOVY | naloxone hydrochloride | SPRAY, METERED;NASAL | 208969 | NDA | International Medication Systems, Ltd. | 76329-3669 | 76329-3669-2 | 2 CONTAINER in 1 CONTAINER (76329-3669-2) / .25 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 4MG/SPRAY | ||||
| Approval Date: | Mar 7, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 7, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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