Details for New Drug Application (NDA): 020459
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NDA 020459 describes REVEX, which is a drug marketed by Hikma and is included in one NDA. Additional details are available on the REVEX profile page.
The generic ingredient in REVEX 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.
The generic ingredient in REVEX 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 020459
| Tradename: | REVEX |
| Applicant: | Hikma |
| Ingredient: | nalmefene hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 17, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 17, 1995 | TE: | RLD: | Yes | |||||
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