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Details for New Drug Application (NDA): 019921

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NDA 019921 describes OCUFLOX, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. Additional details are available on the OCUFLOX profile page.

The generic ingredient in OCUFLOX is ofloxacin. There are sixty-nine 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: 019921

Therapeutic Class:Antibacterials

Pharmacology for NDA: 019921


Suppliers and Packaging for NDA: 019921

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION/DROPS;OPHTHALMIC 019921 NDA Allergan, Inc. 11980-779 11980-779-05 1 BOTTLE, DROPPER in 1 CARTON (11980-779-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Jul 30, 1993TE:ATRLD:Yes

Expired Orange Book Patents for NDA: 019921

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
SOLUTION/DROPS;OPHTHALMIC019921-001Jul 30, 19934,382,892*PED<subscribe>
SOLUTION/DROPS;OPHTHALMIC019921-001Jul 30, 19934,551,456*PED<subscribe>
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