Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062506
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 500,000 UNITS TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/16/1984 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-39 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-38 Manufacturing (CMC)-Facility

Label is not available on this site.

12/21/1999 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/19/1997 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/05/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/02/1997 SUPPL-33 Labeling

Label is not available on this site.

11/26/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/10/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/09/1994 SUPPL-23 Labeling

Label is not available on this site.

01/14/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/14/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/14/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/14/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/14/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/14/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-15 Labeling

Label is not available on this site.

12/03/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 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.

12/03/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

NYSTATIN

TABLET;ORAL; 500,000 UNITS
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NYSTATIN NYSTATIN 500,000 UNITS TABLET;ORAL Prescription No AA 062474 HERITAGE PHARMS INC
NYSTATIN NYSTATIN 500,000 UNITS TABLET;ORAL Prescription No AA 062838 SUN PHARM INDUSTRIES
NYSTATIN NYSTATIN 500,000 UNITS TABLET;ORAL Prescription No AA 062506 TEVA

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