Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062776
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100,000 UNITS/ML 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
12/17/1987 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
08/30/2001 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

08/19/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/19/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/12/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/26/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/26/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/26/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/21/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/09/1994 SUPPL-6 Labeling

Label is not available on this site.

05/21/1992 SUPPL-5 Labeling

Label is not available on this site.

06/01/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/24/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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