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Details for New Drug Application (NDA): 021493

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NDA 021493 describes ZYMAR, which is a drug marketed by Allergan and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZYMAR profile page.

The generic ingredient in ZYMAR is gatifloxacin. There are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the gatifloxacin profile page.

Summary for NDA: 021493

Therapeutic Class:Antibacterials

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Mar 28, 2003TE:RLD:Yes
Patent:5,880,283*PEDPatent Expiration:Jun 5, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,333,045*PEDPatent Expiration:Feb 20, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021493

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
SOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 20034,980,470*PED► subscribe
SOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 20035,880,283*PED► subscribe
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