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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 064063


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NDA 064063 describes NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, which is a drug marketed by Bausch And Lomb, Padagis Us, and Alcon Pharms Ltd, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE is dexamethasone; neomycin sulfate; polymyxin b sulfate. There are thirty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.
Pharmacology for NDA: 064063
Suppliers and Packaging for NDA: 064063
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 064063 ANDA Bausch & Lomb Incorporated 24208-795 24208-795-35 1 TUBE in 1 CARTON (24208-795-35) / 3.5 g in 1 TUBE
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 064063 ANDA A-S Medication Solutions 50090-6181 50090-6181-0 1 TUBE in 1 CARTON (50090-6181-0) / 3.5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:Jul 25, 1994TE:ATRLD:No

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