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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209752
Company: GLAND PHARMA LTD
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 Over-the-counter None 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
05/20/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

OLOPATADINE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION/DROPS;OPHTHALMIC; EQ 0.2% BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 204723 AKORN
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 209420 ALEMBIC PHARMS LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 090918 APOTEX INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 090848 BARR LABS INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 209995 EUGIA PHARMA
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 209752 GLAND PHARMA LTD
PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 021545 ALCON LABS INC
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