Details for New Drug Application (NDA): 074288
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NDA 074288 describes ACEBUTOLOL HYDROCHLORIDE, which is a drug marketed by Amneal Pharm, Ani Pharms, and Norvium Bioscience, and is included in three NDAs. It is available from six suppliers. Additional details are available on the ACEBUTOLOL HYDROCHLORIDE profile page.
The generic ingredient in ACEBUTOLOL HYDROCHLORIDE is acebutolol hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.
The generic ingredient in ACEBUTOLOL HYDROCHLORIDE is acebutolol hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.
Summary for 074288
| Tradename: | ACEBUTOLOL HYDROCHLORIDE |
| Applicant: | Norvium Bioscience |
| Ingredient: | acebutolol hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 074288
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Apr 24, 1995 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Apr 24, 1995 | TE: | RLD: | No | |||||
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