"65145-207-01" National Drug Code (NDC)

Gatifloxacin Ophthalmic Solution 0.5% 1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE
(Caplin Steriles Limited)

NDC Code65145-207-01
Package Description1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE
Product NDC65145-207
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGatifloxacin Ophthalmic Solution 0.5%
Non-Proprietary NameGatifloxacin Ophthalmic Solution 0.5%
Dosage FormSOLUTION
UsageOPHTHALMIC
Start Marketing Date20251006
Marketing Category NameANDA
Application NumberANDA213542
ManufacturerCaplin Steriles Limited
Substance NameGATIFLOXACIN ANHYDROUS
Strength5
Strength Unitmg/mL
Pharmacy ClassesQuinolone Antimicrobial [EPC], Quinolones [CS]

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