Details for New Drug Application (NDA): 019507
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NDA 019507 describes KERLONE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the KERLONE profile page.
The generic ingredient in KERLONE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.
The generic ingredient in KERLONE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.
Summary for 019507
| Tradename: | KERLONE |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | betaxolol hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019507
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 27, 1989 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 27, 1989 | TE: | RLD: | No | |||||
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