Nystatin / Triamcinolone Topical Ointment

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Taro Pharmaceuticals U.S.A., Inc. (2012-11-21)
Oldest Current Product
1985-10-09
License(s)
ANDA
RxNORM
TOPICAL OINTMENT\NYSTATIN:TRIAMCINOLONE
FDAOB
TOPICAL\OINTMENT\NYSTATIN: TRIAMCINOLONE ACETONIDE
SPL Active
TOPICAL\OINTMENT\NYSTATIN: TRIAMCINOLONE ACETONIDE
SPL Moiety
TOPICAL\OINTMENT\NYSTATIN: TRIAMCINOLONE
TOPICAL\OINTMENT\NYSTATIN: TRIAMCINOLONE ACETONIDE

product(s) by strength(s)

nystatin 100 unt/mg / triamcinolone acetonide 0.001 mg/mg topical ointment

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680089ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1985-10-09NYSTATIN, TRIAMCINOLONE ACETONIDETOPICALOINTMENTANDA06260247b09171-bc17-4f32-a08e-6546bd48f78a
2004720155ANDAActavis Pharma, Inc.2015-06-05NYSTATIN, TRIAMCINOLONE ACETONIDETOPICALOINTMENTANDA062733ad9a2d07-f27d-4c38-a74c-b6fdde46fc12
3516721272ANDATaro Pharmaceuticals U.S.A., Inc.1993-03-29NYSTATIN, TRIAMCINOLONE ACETONIDETOPICALOINTMENTANDA0633052fd97fc5-cae5-43dd-a3c7-c9a03876153e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545691143ANDAA-S Medication Solutions Llc1993-03-29NYSTATIN, TRIAMCINOLONE ACETONIDETOPICALOINTMENT516721272ANDA06330533b2f3a7-f1e2-42d8-89bd-a9b616944b32
2548682470ANDAPhysicians Total Care, Inc.2005-03-03NYSTATIN, TRIAMCINOLONE ACETONIDETOPICALOINTMENT516721272ANDA06330506237703-b962-4e9b-9851-fc06070ed1a6

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060572MYCOLOG-IITrueDELCOR ASSET CORP1985-06-28ANDA060572_001
2ANDA062045MYCO-TRIACET IITrueTEVA PHARMACEUTICALS USA INC1985-11-26ANDA062045_002
3ANDA062280NYSTATIN AND TRIAMCINOLONE ACETONIDETruePERRIGO NEW YORK INC1985-10-10ANDA062280_002
4ANDA062601MYTREX FTrueSAVAGE LABORATORIES INC DIV ALTANA INC1985-10-09ANDA062601_001
5ANDA062602NYSTATIN AND TRIAMCINOLONE ACETONIDEE FOUGERA DIV ALTANA INC1985-10-09ANDA062602_001
6ANDA062603NYSTATIN-TRIAMCINOLONE ACETONIDETruePHARMADERM DIV ALTANA INC1985-10-09ANDA062603_001
7ANDA062656NYSTATIN AND TRIAMCINOLONE ACETONIDETruePHARMAFAIR INC1986-07-30ANDA062656_001
8ANDA062733MYKACETG AND W LABORATORIES INC1987-03-09ANDA062733_001
9ANDA063305NYSTATIN AND TRIAMCINOLONE ACETONIDETARO PHARMACEUTICALS USA INC1993-03-29ANDA063305_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060572_001discontinuedNYSTATIN (100,000 UNITS/GM), TRIAMCINOLONE ACETONIDE (0.1%)TOPICALOINTMENTFalse1985-06-28MYCOLOG-II
2ANDA062045_002discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalse1985-11-26MYCO-TRIACET II
3ANDA062280_002discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalse1985-10-10NYSTATIN AND TRIAMCINOLONE ACETONIDE
4ANDA062601_001discontinuedNYSTATIN (100,000 UNITS/GM), TRIAMCINOLONE ACETONIDE (0.1%)TOPICALOINTMENTFalse1985-10-09MYTREX F
5ANDA062602_001RXNYSTATIN (100,000 UNITS/GM), TRIAMCINOLONE ACETONIDE (0.1%)TOPICALOINTMENTFalseAT1985-10-09NYSTATIN AND TRIAMCINOLONE ACETONIDE
6ANDA062603_001discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalse1985-10-09NYSTATIN-TRIAMCINOLONE ACETONIDE
7ANDA062656_001discontinuedNYSTATIN (100,000 UNITS/GM), TRIAMCINOLONE ACETONIDE (0.1%)TOPICALOINTMENTFalse1986-07-30NYSTATIN AND TRIAMCINOLONE ACETONIDE
8ANDA062733_001RXTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalseAT1987-03-09MYKACET
9ANDA063305_001RXTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTTrueAT1993-03-29NYSTATIN AND TRIAMCINOLONE ACETONIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
106237703-b962-4e9b-9851-fc06070ed1a6 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-05-101548682470
22fd97fc5-cae5-43dd-a3c7-c9a03876153e (view SPL)Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USPprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2012-11-213516721272, 516721263Nystatin / Triamcinolone Topical Cream
333b2f3a7-f1e2-42d8-89bd-a9b616944b32 (view SPL)Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691143, 545690774Nystatin / Triamcinolone Topical Cream
447b09171-bc17-4f32-a08e-6546bd48f78a (view SPL)NYSTATINand TRIAMCINOLONE ACETONIDE OINTMENT USPprescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2013-11-274001680089
5ad9a2d07-f27d-4c38-a74c-b6fdde46fc12 (view SPL)Nystatin and Triamcinolone Acetonide Ointment USPRx OnlyFOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.prescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2013-07-2911004720155

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII