Gatifloxacin

Product NDC

57297-435

11-digit product format

572970435

Labeler code

57297

Product ID

57297-435_acc3e700-1d57-4e9f-97b4-a61b2e99814e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Gatifloxacin

Dosage form

SOLUTION/ DROPS

Route

OPHTHALMIC

Labeler

LUPIN LIMITED

Application

ANDA202653

Marketing category

ANDA

Marketing start

2013-10-01

Marketing end

0000-00-00

Substance

GATIFLOXACIN

Active strength

5 mg/mL

Pharmacologic classes

Quinolone Antimicrobial [EPC],Quinolones [CS]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record