Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064142
Company: VISTAPHARM
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
06/25/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64142ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64142ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64142.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/25/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64142ap_appltr_prntlbl_chemr.pdf

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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