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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074850

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NDA 074850 describes LEVOBUNOLOL HYDROCHLORIDE, which is a drug marketed by Alcon Labs Inc, Apotex Inc, Bausch And Lomb, and Sandoz 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 074850
Applicant:Sandoz Inc
Ingredient:levobunolol hydrochloride
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 074850
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 074850
Suppliers and Packaging for NDA: 074850
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOBUNOLOL HYDROCHLORIDE levobunolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 074850 ANDA Sandoz Inc 61314-229 E 61314-229-10
LEVOBUNOLOL HYDROCHLORIDE levobunolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 074850 ANDA Sandoz Inc 61314-229 E 61314-229-15

Profile for product number 001

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

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