Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062472
Company: PERRIGO NEW YORK
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
02/13/1984 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
04/17/2009 SUPPL-4 Labeling

Label is not available on this site.

09/05/2000 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/1994 SUPPL-1 Labeling

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 062124 FOUGERA PHARMS
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 209114 G AND W LABS INC
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 209082 LYNE
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
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 207767 ZYDUS PHARMS USA INC

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