Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061966
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/GM CREAM;TOPICAL Prescription AT 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
05/25/1976 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-25 Manufacturing (CMC)-Facility

Label is not available on this site.

06/13/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/03/1993 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.

08/31/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 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.

04/27/1993 SUPPL-11 Labeling

Label is not available on this site.

08/09/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/25/1992 SUPPL-9 Labeling

Label is not available on this site.

11/10/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

NYSTATIN

CREAM;TOPICAL; 100,000 UNITS/GM
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM;TOPICAL Prescription No AT 062949 ACTAVIS MID ATLANTIC
NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM;TOPICAL Prescription No AT 207733 CROWN LABS INC
NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM;TOPICAL Prescription No AT 062129 FOUGERA PHARMS
NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM;TOPICAL Prescription No AT 061966 G AND W LABS INC
NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM;TOPICAL Prescription No AT 062225 PERRIGO NEW YORK
NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM;TOPICAL Prescription No AT 064022 TARO
NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM;TOPICAL Prescription No AT 065315 VINTAGE

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