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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203152
Company: USV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% 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
12/07/2015 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203152Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203152Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203152Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2021 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/07/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203152Orig1s000lbl.pdf

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 0.1% BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 204532 AKORN
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 209919 ALEMBIC PHARMS LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 078350 APOTEX
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 204812 EUGIA PHARMA
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 209619 GLAND PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 203152 USV
PATADAY TWICE DAILY RELIEF OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 020688 ALCON LABS INC
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