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Last Updated: May 14, 2021

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Details for New Drug Application (NDA): 065006

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NDA 065006 describes TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, which is a drug marketed by Akorn, Bausch And Lomb, and Sandoz Inc, and is included in three NDAs. It is available from eleven 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 twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
Summary for 065006
Suppliers and Packaging for NDA: 065006
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 065006 ANDA Akorn, Inc. 17478-703 17478-703-11 1 BOTTLE, DROPPER in 1 CARTON (17478-703-11) > 10 mL in 1 BOTTLE, DROPPER
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE polymyxin b sulfate; trimethoprim sulfate SOLUTION/DROPS;OPHTHALMIC 065006 ANDA Proficient Rx LP 63187-193 63187-193-10 1 BOTTLE, DROPPER in 1 CARTON (63187-193-10) > 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength10,000 UNITS/ML;EQ 1MG BASE/ML
Approval Date:Dec 17, 1998TE:ATRLD:No

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