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Last Updated: December 15, 2024

Details for New Drug Application (NDA): 075476


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NDA 075476 describes CARTEOLOL HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Bausch And Lomb, and Sandoz, and is included in three NDAs. It is available from one supplier. Additional details are available on the CARTEOLOL HYDROCHLORIDE profile page.

The generic ingredient in CARTEOLOL HYDROCHLORIDE is carteolol hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carteolol hydrochloride profile page.
Summary for 075476
Tradename:CARTEOLOL HYDROCHLORIDE
Applicant:Sandoz
Ingredient:carteolol hydrochloride
Patents:0
Pharmacology for NDA: 075476
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 075476
Suppliers and Packaging for NDA: 075476
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARTEOLOL HYDROCHLORIDE carteolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075476 ANDA Sandoz Inc 61314-238 61314-238-05 5 mL in 1 BOTTLE, PLASTIC (61314-238-05)
CARTEOLOL HYDROCHLORIDE carteolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075476 ANDA Sandoz Inc 61314-238 61314-238-10 10 mL in 1 BOTTLE, PLASTIC (61314-238-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Jan 3, 2000TE:RLD:No

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