Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062876
Company: TARO PHARM
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 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
02/29/1988 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
07/23/2007 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1996 SUPPL-10 Labeling

Label is not available on this site.

07/10/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/30/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/10/1989 SUPPL-5 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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