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Details for New Drug Application (NDA): 064120

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NDA 064120 describes TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, which is a drug marketed by Akorn Inc, Alcon Res Ltd, and Bausch And Lomb, and is included in three NDAs. It is available from twelve suppliers. Additional details are available on the TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE profile page.

The generic ingredient in TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is polymyxin b sulfate; trimethoprim sulfate. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.

Summary for NDA: 064120

Suppliers and Packaging for NDA: 064120

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
polymyxin b sulfate; trimethoprim sulfate
SOLUTION/DROPS;OPHTHALMIC 064120 ANDA Bausch & Lomb Incorporated 24208-315 24208-315-10 1 BOTTLE, DROPPER in 1 CARTON (24208-315-10) > 10 mL in 1 BOTTLE, DROPPER
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
polymyxin b sulfate; trimethoprim sulfate
SOLUTION/DROPS;OPHTHALMIC 064120 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-378 49999-378-10 1 BOTTLE, DROPPER in 1 CARTON (49999-378-10) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength10,000 UNITS/ML;EQ 1MG BASE/ML
Approval Date:Feb 14, 1997TE:ATRLD:No


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