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Harvard Business School
US Department of Justice
Queensland Health
Boehringer Ingelheim

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074447

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NDA 074447 describes FLURBIPROFEN SODIUM, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from five suppliers. Additional details are available on the FLURBIPROFEN SODIUM profile page.

The generic ingredient in FLURBIPROFEN SODIUM is flurbiprofen sodium. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.
Summary for 074447
Applicant:Bausch And Lomb
Ingredient:flurbiprofen sodium
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074447
Suppliers and Packaging for NDA: 074447
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLURBIPROFEN SODIUM flurbiprofen sodium SOLUTION/DROPS;OPHTHALMIC 074447 ANDA Rebel Distributors Corp 21695-615 E 21695-615-25
FLURBIPROFEN SODIUM flurbiprofen sodium SOLUTION/DROPS;OPHTHALMIC 074447 ANDA Bausch & Lomb Incorporated 24208-314 N 24208-314-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.03%
Approval Date:Jan 4, 1995TE:ATRLD:No

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Cantor Fitzgerald
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Fish and Richardson

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