Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062409
Company: ALPHARMA US PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERYTHROMYCIN ESTOLATE 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
12/16/1982 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-23 Labeling

Label is not available on this site.

09/12/2000 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/07/1993 SUPPL-19 Labeling

Label is not available on this site.

10/09/1991 SUPPL-18 Labeling

Label is not available on this site.

09/28/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/26/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/06/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/05/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/26/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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