Nystatin Topical Cream

Brand(s)
Pediaderm AF
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Perrigo New York Inc (2015-08-25)
Oldest Current Product
1979-02-01
License(s)
ANDA
RxNORM
TOPICAL CREAM\NYSTATIN
FDAOB
TOPICAL\CREAM\NYSTATIN
TOPICAL\CREAM\NYSTATIN: TRIAMCINOLONE ACETONIDE
SPL Active
TOPICAL\CREAM\NYSTATIN
SPL Moiety
TOPICAL\CREAM\NYSTATIN

product(s) by strength(s)

nystatin 100000 unt/ml topical cream

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1006037818Qualitest PharmaceuticalsNYSTATINTOPICALCREAMfc141ac5-c14e-4abf-8f2f-98b50a0c63a4

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680054ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1979-02-01NYSTATINTOPICALCREAMANDA062129c9e28323-21fa-4547-b70c-27dc13a5bd7e
2004720163ANDAActavis Pharma, Inc.2010-07-21NYSTATINTOPICALCREAMANDA062949a4cba0e2-d280-419f-819b-b0104b031468
3007130678ANDAG&W Laboratories, Inc.2015-04-01NYSTATINTOPICALCREAMANDA061966ec1b52af-d38e-eba1-e63c-dba4341d3af2
4243380320Pediaderm AFANDAArbor Pharmaceuticals, Inc.2011-01-01ANDA062364bb68ae89-8a87-4ff7-a71b-f47ed4da1808
5243380516ANDAArbor Pharmaceuticals, Inc.1993-01-28NYSTATINTOPICALCREAMANDA0640223dca3608-fd19-4bf2-9702-bd25621cec88
6458020059ANDAPerrigo New York Inc2006-09-21NYSTATINTOPICALCREAMANDA062225e630aa3d-11a6-4300-942a-cbdf2d016f77
7516721289ANDATaro Pharmaceuticals U.S.A., Inc.1993-01-28NYSTATINTOPICALCREAMANDA0640224d845b3f-ca26-4c47-b424-b6d783cc10e5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1499990251ANDALake Erie Medical Dba Quality Care Products Llc2006-05-31NYSTATINTOPICALCREAM006037818ANDA065315cd1a57eb-7093-4c50-a9b4-cd011cf974b3
2521250708ANDARemedyrepack Inc.2013-09-19NYSTATINTOPICALCREAM006037818ANDA065315c0378699-54ba-42d1-b11e-4945ba4e00ac
3545691125ANDAA-S Medication Solutions Llc2006-05-31NYSTATINTOPICALCREAM006037818ANDA0653151b8084d6-ce44-49b3-8865-a198d784c6f4
4545691155ANDAA-S Medication Solutions Llc2006-05-31NYSTATINTOPICALCREAM006037818ANDA06531532df1ffd-d6b6-45a9-9692-774d88563b5d
5548680242ANDAPhysicians Total Care, Inc.1995-01-31NYSTATINTOPICALCREAM516721289ANDA064022bdb80797-20c8-4fbc-8ef8-b85d6aebdce5
6631870422ANDAProficient Rx Lp2010-07-21NYSTATINTOPICALCREAM004720163ANDA062949b9d5a099-00ef-40b6-90a4-254f2be551d5
7682583046ANDADispensing Solutions, Inc.2006-05-31NYSTATINTOPICALCREAM006037818ANDA065315377b0312-abfe-45eb-9e6e-ae348ec83325
8687880178ANDAPreferred Pharmaceuticals, Inc.2014-01-13NYSTATINTOPICALCREAM006037818ANDA065315a6b33844-2be4-417e-90b9-e5e3914741a2
9687889247ANDAPreferred Pharmaceuticals, Inc.2014-11-13NYSTATINTOPICALCREAM001680054ANDA06212928051258-478b-4c8e-ab48-3c3f40de2321

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA060575MYCOSTATINTrueDELCOR ASSET CORPANDA060575_001
2ANDA060576MYCOLOG-IITrueDELCOR ASSET CORP1985-05-01ANDA060576_002Nystatin / Triamcinolone Topical Cream
3ANDA061445NILSTATTrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA061445_001
4ANDA061810CANDEXTrueBAYER PHARMACEUTICALS CORPANDA061810_001
5ANDA061954MYCO-TRIACET IITrueTEVA PHARMACEUTICALS USA INC1985-09-20ANDA061954_002Nystatin / Triamcinolone Topical Cream
6ANDA061966NYSTATING AND W LABORATORIES INCANDA061966_001
7ANDA062129NYSTATINFOUGERA PHARMACEUTICALS INCANDA062129_001
8ANDA062186NYSTATIN AND TRIAMCINOLONE ACETONIDETruePERRIGO NEW YORK INC1985-06-06ANDA062186_002Nystatin / Triamcinolone Topical Cream
9ANDA062225NYSTATINPERRIGO NEW YORK INCANDA062225_001
10ANDA062347NYSTATIN AND TRIAMCINOLONE ACETONIDETrueTARO PHARMACEUTICALS USA INC1987-03-30ANDA062347_001Nystatin / Triamcinolone Topical Cream
11ANDA062364NYSTATIN AND TRIAMCINOLONE ACETONIDETARO PHARMACEUTICALS USA INC1987-12-22ANDA062364_001Nystatin / Triamcinolone Topical Cream
12ANDA062367MYKACETG AND W LABORATORIES INC1985-05-28ANDA062367_001Nystatin / Triamcinolone Topical Cream
13ANDA062387MYKINACTrueALPHARMA US PHARMACEUTICALS DIVISION1982-07-29ANDA062387_001
14ANDA062457NYSTATINTrueTARO PHARMACEUTICALS USA INC1983-07-28ANDA062457_001
15ANDA062596NYSTATIN-TRIAMCINOLONE ACETONIDETruePHARMADERM DIV ALTANA INC1985-10-08ANDA062596_001Nystatin / Triamcinolone Topical Cream
16ANDA062597MYTREX FTrueSAVAGE LABORATORIES INC DIV ALTANA INC1985-10-08ANDA062597_001Nystatin / Triamcinolone Topical Cream
17ANDA062599NYSTATIN AND TRIAMCINOLONE ACETONIDEE FOUGERA DIV ALTANA INC1985-10-08ANDA062599_001Nystatin / Triamcinolone Topical Cream
18ANDA062606MYCOLOG-IITrueDELCOR ASSET CORP1985-05-15ANDA062606_001Nystatin / Triamcinolone Topical Cream
19ANDA062657NYSTATIN AND TRIAMCINOLONE ACETONIDETruePHARMAFAIR INC1986-07-30ANDA062657_001Nystatin / Triamcinolone Topical Cream
20ANDA062949NYSTATINACTAVIS MID ATLANTIC LLC1988-06-13ANDA062949_001
21ANDA063010NYSTATIN AND TRIAMCINOLONE ACETONIDETrueALPHARMA US PHARMACEUTICALS DIVISION1988-12-20ANDA063010_001Nystatin / Triamcinolone Topical Cream
22ANDA064022NYSTATINTARO PHARMACEUTICALS USA INC1993-01-29ANDA064022_001
23ANDA065315NYSTATINVINTAGE PHARMACEUTICALS LLC2006-05-31ANDA065315_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060575_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseMYCOSTATIN
2ANDA060576_002discontinuedNYSTATIN (100,000 UNITS/GM), TRIAMCINOLONE ACETONIDE (0.1%)TOPICALCREAMFalse1985-05-01MYCOLOG-II
3ANDA061445_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseNILSTAT
4ANDA061810_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseCANDEX
5ANDA061954_002discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1985-09-20MYCO-TRIACET II
6ANDA061966_001RXNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseATNYSTATIN
7ANDA062129_001RXNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseATNYSTATIN
8ANDA062186_002discontinuedNYSTATIN (100,000 UNITS/GM), TRIAMCINOLONE ACETONIDE (0.1%)TOPICALCREAMFalse1985-06-06NYSTATIN AND TRIAMCINOLONE ACETONIDE
9ANDA062225_001RXNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseATNYSTATIN
10ANDA062347_001discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1987-03-30NYSTATIN AND TRIAMCINOLONE ACETONIDE
11ANDA062364_001RXNYSTATIN (100,000 UNITS/GM), TRIAMCINOLONE ACETONIDE (0.1%)TOPICALCREAMTrueAT1987-12-22NYSTATIN AND TRIAMCINOLONE ACETONIDE
12ANDA062367_001RXTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseAT1985-05-28MYKACET
13ANDA062387_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1982-07-29MYKINAC
14ANDA062457_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1983-07-28NYSTATIN
15ANDA062596_001discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1985-10-08NYSTATIN-TRIAMCINOLONE ACETONIDE
16ANDA062597_001discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1985-10-08MYTREX F
17ANDA062599_001RXNYSTATIN (100,000 UNITS/GM), TRIAMCINOLONE ACETONIDE (0.1%)TOPICALCREAMFalseAT1985-10-08NYSTATIN AND TRIAMCINOLONE ACETONIDE
18ANDA062606_001discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1985-05-15MYCOLOG-II
19ANDA062657_001discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1986-07-30NYSTATIN AND TRIAMCINOLONE ACETONIDE
20ANDA062949_001RXNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseAT1988-06-13NYSTATIN
21ANDA063010_001discontinuedTRIAMCINOLONE ACETONIDE (0.1%), NYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalse1988-12-20NYSTATIN AND TRIAMCINOLONE ACETONIDE
22ANDA064022_001RXNYSTATIN (100,000 UNITS/GM)TOPICALCREAMTrueAT1993-01-29NYSTATIN
23ANDA065315_001RXNYSTATIN (100,000 UNITS/GM)TOPICALCREAMFalseAT2006-05-31NYSTATIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11b8084d6-ce44-49b3-8865-a198d784c6f4 (view SPL)NYSTATIN CREAM, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691125
228051258-478b-4c8e-ab48-3c3f40de2321 (view SPL)NYSTATIN CREAM USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-11-131687889247
332df1ffd-d6b6-45a9-9692-774d88563b5d (view SPL)NYSTATIN CREAM, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691155
4377b0312-abfe-45eb-9e6e-ae348ec83325 (view SPL)NYSTATIN CREAM, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-101682583046
53dca3608-fd19-4bf2-9702-bd25621cec88 (view SPL)NystatinCream USP, 100,000 units per gramprescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.MANUFACTURE2012-09-141243380516
64d845b3f-ca26-4c47-b424-b6d783cc10e5 (view SPL)Nystatin Cream USP, 100,000 units per gramprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2012-11-143516721289
7a4cba0e2-d280-419f-819b-b0104b031468 (view SPL)NYSTATIN CREAM USPprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, MANUFACTURE2006-01-204004720163
8a6b33844-2be4-417e-90b9-e5e3914741a2 (view SPL)NYSTATIN CREAM, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-01-231687880178
9b9d5a099-00ef-40b6-90a4-254f2be551d5 (view SPL)NYSTATIN CREAM USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-03-271631870422
10bb68ae89-8a87-4ff7-a71b-f47ed4da1808 (view SPL)pediaderm AF Complete KitprescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.2013-10-162243380320
11bdb80797-20c8-4fbc-8ef8-b85d6aebdce5 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-05-101548680242
12c0378699-54ba-42d1-b11e-4945ba4e00ac (view SPL)NYSTATIN CREAM, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-192521250708
13c9e28323-21fa-4547-b70c-27dc13a5bd7e (view SPL)NYSTATIN CREAM USPprescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-05-096001680054
14cd1a57eb-7093-4c50-a9b4-cd011cf974b3 (view SPL)NYSTATIN CREAM, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2015-05-261499990251
15e630aa3d-11a6-4300-942a-cbdf2d016f77 (view SPL)NYSTATIN CREAM USP DRUG FACTSprescriptionHuman PrescriptionPerrigo New York Inc2015-08-254458020059
16ec1b52af-d38e-eba1-e63c-dba4341d3af2 (view SPL)prescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2014-10-133007130678
17fc141ac5-c14e-4abf-8f2f-98b50a0c63a4 (view SPL)NYSTATIN CREAM, USPprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-06-294006037818

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