Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062311
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIKIN AMIKACIN SULFATE EQ 50MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
AMIKIN AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION 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
01/22/1981 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
09/17/2001 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

05/30/2000 SUPPL-26 Labeling

Label is not available on this site.

07/31/1996 SUPPL-25 Labeling

Label is not available on this site.

07/22/1993 SUPPL-24 Labeling

Label is not available on this site.

11/16/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/29/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/19/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/16/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/09/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/29/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/12/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/24/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/17/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/03/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/22/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/16/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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