Details for New Drug Application (NDA): 217992
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The generic ingredient in NALOXONE HYDROCHLORIDE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.
Summary for 217992
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Amneal |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217992
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 217992
Suppliers and Packaging for NDA: 217992
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | SPRAY, METERED;NASAL | 217992 | ANDA | Walgreen Co. | 0363-2140 | 0363-2140-02 | 2 VIAL in 1 CARTON (0363-2140-02) / .1 mL in 1 VIAL (0363-2140-01) |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | SPRAY, METERED;NASAL | 217992 | ANDA | AvKARE | 42291-493 | 42291-493-02 | 2 VIAL, SINGLE-DOSE in 1 CARTON (42291-493-02) / .1 mL in 1 VIAL, SINGLE-DOSE (42291-493-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 4MG/SPRAY | ||||
Approval Date: | Apr 23, 2024 | TE: | RLD: | No |
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