Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062304
Company: ARBOR PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEDIAMYCIN ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML SUSPENSION;ORAL Discontinued None No No
PEDIAMYCIN 400 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML SUSPENSION;ORAL Discontinued 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
12/18/1980 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
04/28/2016 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

08/07/2006 SUPPL-28 Labeling

Label is not available on this site.

10/07/2004 SUPPL-26 Labeling

Label is not available on this site.

10/02/2001 SUPPL-23 Labeling

Label is not available on this site.

03/13/2001 SUPPL-22 Labeling

Label is not available on this site.

05/29/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/2000 SUPPL-20 Labeling

Label is not available on this site.

12/09/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/28/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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