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Details for New Drug Application (NDA): 064211

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NDA 064211 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 thirteen 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. Twenty suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.

Summary for NDA: 064211

Tradename:
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Applicant:
Alcon Res Ltd
Ingredient:
polymyxin b sulfate; trimethoprim sulfate
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 064211

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 064211 ANDA STAT RX LLC USA 16590-233 16590-233-10 1 BOTTLE, DROPPER in 1 CARTON (16590-233-10) > 10 mL in 1 BOTTLE, DROPPER
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
polymyxin b sulfate; trimethoprim sulfate
SOLUTION/DROPS;OPHTHALMIC 064211 ANDA Rebel Distributors Corp 21695-335 21695-335-10 10 mL in 1 BOTTLE, PLASTIC (21695-335-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength10,000 UNITS/ML;EQ 1MG BASE/ML
Approval Date:Apr 13, 1998TE:ATRLD:No


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