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Details for New Drug Application (NDA): 090395

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NDA 090395 describes OFLOXACIN, which is a drug marketed by Akorn, Apotex Inc, Hi Tech Pharma, Ranbaxy Labs Ltd, Bausch And Lomb, Alcon Pharms Ltd, 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-three 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-four suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

Summary for NDA: 090395

Tradename:
OFLOXACIN
Applicant:
Alvogen
Ingredient:
ofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 090395

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 090395

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN
ofloxacin
SOLUTION/DROPS;OTIC 090395 ANDA PharmaForce, Inc. 40042-049 40042-049-05 1 BOTTLE, PLASTIC in 1 CARTON (40042-049-05) > 5 mL in 1 BOTTLE, PLASTIC
OFLOXACIN
ofloxacin
SOLUTION/DROPS;OTIC 090395 ANDA PharmaForce, Inc. 40042-049 40042-049-10 1 BOTTLE, PLASTIC in 1 CARTON (40042-049-10) > 10 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength0.3%
Approval Date:Aug 11, 2009TE:ATRLD:No


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