Details for New Drug Application (NDA): 020315
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NDA 020315 describes ORLAAM, which is a drug marketed by Roxane and is included in one NDA. Additional details are available on the ORLAAM profile page.
The generic ingredient in ORLAAM is levomethadyl acetate hydrochloride. There is one drug master file entry for this compound. Additional details are available on the levomethadyl acetate hydrochloride profile page.
The generic ingredient in ORLAAM is levomethadyl acetate hydrochloride. There is one drug master file entry for this compound. Additional details are available on the levomethadyl acetate hydrochloride profile page.
Summary for 020315
| Tradename: | ORLAAM |
| Applicant: | Roxane |
| Ingredient: | levomethadyl acetate hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CONCENTRATE;ORAL | Strength | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 9, 1993 | TE: | RLD: | Yes | |||||
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