Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062847
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE TABLET;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
09/14/1988 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
12/10/2001 SUPPL-17 Labeling

Label is not available on this site.

02/23/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/21/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/05/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/22/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/08/1993 SUPPL-9 Labeling

Label is not available on this site.

12/09/1991 SUPPL-8 Labeling

Label is not available on this site.

12/09/1991 SUPPL-7 Labeling

Label is not available on this site.

08/06/1991 SUPPL-6 Labeling

Label is not available on this site.

12/09/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/03/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/17/1991 SUPPL-2 Labeling

Label is not available on this site.

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