Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207767
Company: CADILA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;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
05/25/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

NYSTATIN

OINTMENT;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 OINTMENT;TOPICAL Prescription No AT 062840 ACTAVIS MID ATLANTIC
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 207767 CADILA
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 209114 COSETTE
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 062124 FOUGERA PHARMS
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 209082 LYNE
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 213826 MACLEODS PHARMS LTD
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 062472 PERRIGO NEW YORK
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 211838 TORRENT

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