Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065315
Company: VINTAGE
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
05/31/2006 ORIG-1 Approval

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 061966 ACP NIMBLE
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 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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