Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062512
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;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
10/29/1984 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
03/20/2002 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

07/11/1997 SUPPL-15 Labeling

Label is not available on this site.

09/03/1996 SUPPL-14 Labeling

Label is not available on this site.

10/20/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/11/1994 SUPPL-11 Labeling

Label is not available on this site.

03/25/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/10/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

NYSTATIN

SUSPENSION;ORAL; 100,000 UNITS/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 062517 FOUGERA PHARMS INC
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 064042 HI TECH PHARMA
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 065148 LANNETT CO INC
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 203621 PHARM ASSOC
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 062876 TARO PHARM
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 064142 VISTAPHARM
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 065422 VISTAPHARM
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 062512 WOCKHARDT BIO AG

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