Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062353
Company: ALPHARMA US PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERYTHROMYCIN ESTOLATE ERYTHROMYCIN ESTOLATE EQ 125MG 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
11/18/1982 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
01/18/2001 SUPPL-26 Labeling

Label is not available on this site.

09/11/2000 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/07/1993 SUPPL-20 Labeling

Label is not available on this site.

10/09/1991 SUPPL-19 Labeling

Label is not available on this site.

01/27/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/06/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/24/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/18/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/26/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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