Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065138
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER;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
07/23/2004 ORIG-1 Approval

Label is not available on this site.

NYSTATIN

POWDER;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 POWDER;TOPICAL Prescription No AT 210532 EPIC PHARMA LLC
NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER;TOPICAL Prescription No AT 065138 LUPIN
NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER;TOPICAL Prescription No AT 208838 LYNE
NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER;TOPICAL Prescription No AT 065203 MAYNE PHARMA INC
NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER;TOPICAL Prescription No AT 208581 NESHER PHARMS
NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER;TOPICAL Prescription No AT 065183 UPSHER SMITH LABS
NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER;TOPICAL Prescription No AT 065175 X GEN PHARMS
NYSTOP NYSTATIN 100,000 UNITS/GM POWDER;TOPICAL Prescription No AT 064118 PADDOCK LLC

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