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Details for New Drug Application (NDA): 076128

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NDA 076128 describes OFLOXACIN, which is a drug marketed by Akorn, Apotex Inc, Hi Tech Pharma, Ranbaxy Labs Ltd, Bausch And Lomb, Sandoz Inc, Alvogen, Sandoz, Cadila Pharms Ltd, Fdc Ltd, Bedford, Teva, Altaire Pharms Inc, Larken Labs, and Dr Reddys Labs Ltd, and is included in twenty NDAs. It is available from thirty-one suppliers. Additional details are available on the OFLOXACIN profile page.

The generic ingredient in OFLOXACIN is ofloxacin. There are seventy drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

Summary for NDA: 076128

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 076128


Suppliers and Packaging for NDA: 076128

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION/DROPS;OTIC 076128 ANDA Bausch & Lomb Incorporated 24208-410 24208-410-05 1 BOTTLE, DROPPER in 1 CARTON (24208-410-05) > 5 mL in 1 BOTTLE, DROPPER
SOLUTION/DROPS;OTIC 076128 ANDA Bausch & Lomb Incorporated 24208-410 24208-410-10 1 BOTTLE, DROPPER in 1 CARTON (24208-410-10) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength0.3%
Approval Date:Mar 17, 2008TE: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.