Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062838
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 500,000 UNITS TABLET;ORAL Prescription AA 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
12/22/1988 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
06/28/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/30/1998 SUPPL-5 Labeling

Label is not available on this site.

02/24/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/15/1994 SUPPL-2 Labeling

Label is not available on this site.

01/12/1994 SUPPL-1 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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