"57297-435-01" National Drug Code (NDC)

Gatifloxacin 1 BOTTLE in 1 CARTON (57297-435-01) > 2.5 mL in 1 BOTTLE
(LUPIN LIMITED)

NDC Code57297-435-01
Package Description1 BOTTLE in 1 CARTON (57297-435-01) > 2.5 mL in 1 BOTTLE
Product NDC57297-435
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGatifloxacin
Non-Proprietary NameGatifloxacin
Dosage FormSOLUTION/ DROPS
UsageOPHTHALMIC
Start Marketing Date20131001
Marketing Category NameANDA
Application NumberANDA202653
ManufacturerLUPIN LIMITED
Substance NameGATIFLOXACIN
Strength5
Strength Unitmg/mL
Pharmacy ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]

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