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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077764
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APRACLONIDINE HYDROCHLORIDE APRACLONIDINE HYDROCHLORIDE EQ 0.5% 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
03/12/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077764s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/28/2022 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

09/28/2022 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

APRACLONIDINE HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APRACLONIDINE HYDROCHLORIDE APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077764 AKORN
IOPIDINE APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020258 IMPRIMIS PHARMS USA
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