Details for New Drug Application (NDA): 212955
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The generic ingredient in NALMEFENE HYDROCHLORIDE is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.
Summary for 212955
Tradename: | NALMEFENE HYDROCHLORIDE |
Applicant: | Purdue Pharma Lp |
Ingredient: | nalmefene hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212955
Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 212955
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 212955 | ANDA | Purdue Pharma L.P. | 59011-960 | 59011-960-10 | 10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) | ||||
Approval Date: | Feb 8, 2022 | TE: | AP | RLD: | No |
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