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Last Updated: May 24, 2024

Details for New Drug Application (NDA): 018634

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NDA 018634 describes BETADINE, which is a drug marketed by Alcon Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the BETADINE profile page.

The generic ingredient in BETADINE is povidone-iodine. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the povidone-iodine profile page.
Summary for 018634
Applicant:Alcon Pharms Ltd
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018634
Suppliers and Packaging for NDA: 018634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETADINE povidone-iodine SOLUTION/DROPS;OPHTHALMIC 018634 NDA Alcon Laboratories, Inc. 0065-0411 0065-0411-30 1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength5%
Approval Date:Dec 17, 1986TE:RLD:Yes

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