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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063211
Company: PADAGIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERYTHROMYCIN ERYTHROMYCIN 2% GEL;TOPICAL 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
01/29/1993 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
03/31/2008 SUPPL-3 Labeling

Label is not available on this site.

ERYTHROMYCIN

GEL;TOPICAL; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERYGEL ERYTHROMYCIN 2% GEL;TOPICAL Prescription Yes AT 050617 MYLAN
ERYTHROMYCIN ERYTHROMYCIN 2% GEL;TOPICAL Prescription No AT 064184 FOUGERA PHARMS
ERYTHROMYCIN ERYTHROMYCIN 2% GEL;TOPICAL Prescription No AT 063211 PADAGIS US
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