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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 three 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 NDA: 074447

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
SOLUTION/DROPS;OPHTHALMIC 074447 ANDA Rebel Distributors Corp 21695-615 21695-615-25 2.5 mL in 1 BOTTLE, DROPPER (21695-615-25)
flurbiprofen sodium
SOLUTION/DROPS;OPHTHALMIC 074447 ANDA Bausch & Lomb Incorporated 24208-314 24208-314-25 1 BOTTLE, DROPPER in 1 CARTON (24208-314-25) > 2.5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.