Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062349
Company: G AND W LABS INC
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
07/14/1982 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
10/17/2001 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/16/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/03/1997 SUPPL-28 Labeling

Label is not available on this site.

05/08/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/15/1994 SUPPL-26 Labeling

Label is not available on this site.

01/14/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/08/1993 SUPPL-24 Labeling

Label is not available on this site.

11/09/1992 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/16/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/11/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/11/1990 SUPPL-18 Labeling

Label is not available on this site.

07/24/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/07/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/26/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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