Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062759
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL EQ 200MG BASE/5ML;EQ 600MG BASE/5ML GRANULE;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
05/20/1988 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
12/16/2015 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/21/1999 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/26/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/08/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/03/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/28/1993 SUPPL-22 Labeling

Label is not available on this site.

11/08/1993 SUPPL-21 Labeling

Label is not available on this site.

02/01/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/13/1992 SUPPL-16 Labeling

Label is not available on this site.

10/30/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/06/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/06/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/06/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/01/1995 SUPPL-10 Labeling

Label is not available on this site.

03/31/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/08/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/08/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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