Details for New Drug Application (NDA): 074326
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NDA 074326 describes LEVOBUNOLOL HYDROCHLORIDE, which is a drug marketed by Alcon Labs Inc, Apotex Inc, Bausch And Lomb, and Chartwell Rx, and is included in six NDAs. It is available from one supplier. Additional details are available on the LEVOBUNOLOL HYDROCHLORIDE profile page.
The generic ingredient in LEVOBUNOLOL HYDROCHLORIDE is levobunolol hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levobunolol hydrochloride profile page.
The generic ingredient in LEVOBUNOLOL HYDROCHLORIDE is levobunolol hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levobunolol hydrochloride profile page.
Summary for 074326
| Tradename: | LEVOBUNOLOL HYDROCHLORIDE |
| Applicant: | Bausch And Lomb |
| Ingredient: | levobunolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 074326
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 074326
Suppliers and Packaging for NDA: 074326
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOBUNOLOL HYDROCHLORIDE | levobunolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 074326 | ANDA | Bausch & Lomb Incorporated | 24208-505 | 24208-505-05 | 1 BOTTLE, DROPPER in 1 CARTON (24208-505-05) / 5 mL in 1 BOTTLE, DROPPER |
| LEVOBUNOLOL HYDROCHLORIDE | levobunolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 074326 | ANDA | Bausch & Lomb Incorporated | 24208-505 | 24208-505-10 | 1 BOTTLE, DROPPER in 1 CARTON (24208-505-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Mar 4, 1994 | TE: | AT | RLD: | No | ||||
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