Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209469
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT1 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

MOXIFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 202916 AKORN
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 209469 ALEMBIC PHARMS LTD
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 090080 APOTEX INC
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 206242 AUROBINDO PHARMA LTD
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 202867 LUPIN LTD
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 202525 WATSON LABS INC
VIGAMOX MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT1 021598 NOVARTIS PHARMS CORP

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