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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 two suppliers. Additional details are available on the BETADINE profile page.

The generic ingredient in BETADINE is povidone-iodine. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the povidone-iodine profile page.

Summary for NDA: 018634

Alcon Pharms Ltd
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 018634

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
SOLUTION/DROPS;OPHTHALMIC 018634 NDA Rebel Distributors Corp 42254-006 42254-006-30 30 mL in 1 BOTTLE (42254-006-30)

Summary for product number 001

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

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