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Generated: December 13, 2018

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Details for New Drug Application (NDA): 062938

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NDA 062938 describes NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, which is a drug marketed by Bausch And Lomb, Perrigo Co Tennessee, and Alcon Pharms Ltd, and is included in three NDAs. It is available from fifteen 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. Twenty-one suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.
Pharmacology for NDA: 062938
Suppliers and Packaging for NDA: 062938
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 062938 ANDA Paddock Laboratories, LLC 0574-4160 0574-4160-35 1 TUBE in 1 CARTON (0574-4160-35) > 3.5 g in 1 TUBE
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 062938 ANDA Putney, Inc. 26637-941 26637-941-41 1 TUBE in 1 CARTON (26637-941-41) > 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 31, 1989TE:ATRLD:No

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