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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063038
Company: PADAGIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERYTHROMYCIN ERYTHROMYCIN 2% SOLUTION;TOPICAL Prescription AT No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/11/1991 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
04/24/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
01/10/1992 SUPPL-1 Labeling

Label is not available on this site.

ERYTHROMYCIN

SOLUTION;TOPICAL; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERYTHRA-DERM ERYTHROMYCIN 2% SOLUTION;TOPICAL Prescription No AT 062687 MICRO LABS
ERYTHROMYCIN ERYTHROMYCIN 2% SOLUTION;TOPICAL Prescription No AT 063038 PADAGIS US
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