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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064030
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERYTHROMYCIN ERYTHROMYCIN 0.5% OINTMENT;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
07/18/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/10/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/01/2010 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

ERYTHROMYCIN

OINTMENT;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERYTHROMYCIN ERYTHROMYCIN 0.5% OINTMENT;OPHTHALMIC Prescription No AT 064030 AKORN
ERYTHROMYCIN ERYTHROMYCIN 0.5% OINTMENT;OPHTHALMIC Prescription No AT 064067 BAUSCH AND LOMB
ERYTHROMYCIN ERYTHROMYCIN 0.5% OINTMENT;OPHTHALMIC Prescription No AT 062447 PADAGIS US
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