Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050010
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ILOSONE ERYTHROMYCIN ESTOLATE EQ 125MG BASE/5ML SUSPENSION;ORAL Discontinued None No No
ILOSONE ERYTHROMYCIN ESTOLATE EQ 250MG 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
04/13/1967 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
10/16/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/24/1997 SUPPL-22 Labeling

Label is not available on this site.

10/28/1993 SUPPL-19 Labeling

Label is not available on this site.

04/18/1994 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1992 SUPPL-16 Labeling

Label is not available on this site.

08/22/1991 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1992 SUPPL-12 Labeling

Label is not available on this site.

04/16/1990 SUPPL-9 Labeling

Label is not available on this site.

01/07/1991 SUPPL-8 Labeling

Label is not available on this site.

12/10/1990 SUPPL-7 Labeling

Label is not available on this site.

12/10/1990 SUPPL-6 Labeling

Label is not available on this site.

04/10/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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