Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061894
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
ILOSONE ERYTHROMYCIN ESTOLATE EQ 100MG BASE/ML SUSPENSION/DROPS;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
01/07/1975 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
07/22/1997 SUPPL-19 Labeling

Label is not available on this site.

01/27/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/13/1991 SUPPL-13 Labeling

Label is not available on this site.

01/14/1991 SUPPL-12 Labeling

Label is not available on this site.

04/16/1990 SUPPL-11 Labeling

Label is not available on this site.

09/05/1991 SUPPL-10 Labeling

Label is not available on this site.

11/13/1991 SUPPL-9 Labeling

Label is not available on this site.

04/10/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/10/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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