Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090918
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
12/05/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090918Orig1s000ltr.pdf

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.2% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204723 AKORN
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209420 ALEMBIC PHARMS LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090918 APOTEX INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209995 AUROBINDO PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090848 BARR LABS INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206087 CIPLA
PATADAY OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021545 NOVARTIS

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