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Details for New Drug Application (NDA): 074850

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NDA 074850 describes LEVOBUNOLOL HYDROCHLORIDE, which is a drug marketed by Bausch And Lomb, Sandoz Inc, Alcon Labs Inc, and Apotex Inc, and is included in six NDAs. It is available from three suppliers. 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. Five suppliers are listed for this compound. Additional details are available on the levobunolol hydrochloride profile page.

Summary for NDA: 074850

Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 074850

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 074850

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
levobunolol hydrochloride
SOLUTION/DROPS;OPHTHALMIC 074850 ANDA Sandoz Inc 61314-229 61314-229-05 5 mL in 1 BOTTLE, PLASTIC (61314-229-05)
levobunolol hydrochloride
SOLUTION/DROPS;OPHTHALMIC 074850 ANDA Sandoz Inc 61314-229 61314-229-10 10 mL in 1 BOTTLE, PLASTIC (61314-229-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Oct 28, 1996TE:ATRLD:No

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