Nystatin Topical Powder

Brand(s)
Nyamyc, Nystop
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mayne Pharma Inc. (2009-08-31)
Oldest Current Product
1996-08-16
License(s)
ANDA
RxNORM
TOPICAL POWDER\NYSTATIN
FDAOB
TOPICAL\POWDER\NYSTATIN
SPL Active
CUTANEOUS\POWDER\NYSTATIN
TOPICAL\POWDER\NYSTATIN
SPL Moiety
CUTANEOUS\POWDER\NYSTATIN
TOPICAL\POWDER\NYSTATIN

product(s) by strength(s)

nystatin 100 unt/mg topical powder

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005742008NystopANDAPaddock Laboratories, Llc1996-08-16NYSTATINTOPICALPOWDERANDA064118e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f
2008320465NyamycANDAUpsher-Smith Laboratories, Inc.2005-05-03NYSTATINCUTANEOUSPOWDERANDA06518301b44f91-9b68-464a-9693-b5d3e793bf3c
3009046456ANDAMajor2015-02-15NYSTATINTOPICALPOWDERANDA065138ce5a8256-ff1b-45eb-b1cf-c863cdff97c5
4398223015ANDAX-Gen Pharmaceuticals, Inc.2004-08-30NYSTATINTOPICALPOWDERANDA065175a6f88015-4cac-4cb2-9012-92cc5390b5df
5425430052ANDAVensun Pharmaceuticals, Inc.2014-09-01NYSTATINTOPICALPOWDERANDA065175f64aacd0-4d8b-4a21-bfcb-8eb183bc6d86
6433860530ANDAGavis Pharmaceuticals, Llc2014-09-26NYSTATINTOPICALPOWDERANDA065138cf863efe-53d7-4654-94fc-6530ecdff921
7683080152ANDAMayne Pharma Inc.2004-07-15NYSTATINTOPICALPOWDERANDA065203656fc23b-65af-465e-9bcb-67fbbfa9b84e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540303ANDARebel Distributors Corp2009-09-15NYSTATINTOPICALPOWDER683080152ANDA0652031211504c-f89b-42ed-9d7a-2e1a658a9ccf
2548685216ANDAPhysicians Total Care, Inc.2005-01-27NYSTATINTOPICALPOWDER005742008ANDA064118d62d9d90-3ef2-4697-b6d5-bdb892394998
3765191007ANDAH.J. Harkins Company, Inc.2009-09-15NYSTATINTOPICALPOWDER683080152ANDA0652039e122c5f-65e4-4c92-aaa0-ae97dd725b1a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060578MYCOSTATINTrueDELCOR ASSET CORPANDA060578_001
2ANDA064118NYSTOPPADDOCK LABORATORIES LLC1996-08-16ANDA064118_001
3ANDA065138NYSTATINGAVIS PHARMACEUTICALS LLC2004-07-23ANDA065138_001
4ANDA065175NYSTATINX GEN PHARMACEUTICALS INC2004-12-17ANDA065175_001
5ANDA065183NYSTATINUPSHER SMITH LABORATORIES INC2005-05-03ANDA065183_001
6ANDA065203NYSTATINCOASTAL PHARMACEUTICALS2004-07-15ANDA065203_001
7ANDA065321NYSTATINTrueNESHER PHARMACEUTICALS USA LLC2006-08-18ANDA065321_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060578_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALPOWDERFalseMYCOSTATIN
2ANDA064118_001RXNYSTATIN (100,000 UNITS/GM)TOPICALPOWDERFalseAT1996-08-16NYSTOP
3ANDA065138_001RXNYSTATIN (100,000 UNITS/GM)TOPICALPOWDERFalseAT2004-07-23NYSTATIN
4ANDA065175_001RXNYSTATIN (100,000 UNITS/GM)TOPICALPOWDERFalseAT2004-12-17NYSTATIN
5ANDA065183_001RXNYSTATIN (100,000 UNITS/GM)TOPICALPOWDERFalseAT2005-05-03NYSTATIN
6ANDA065203_001RXNYSTATIN (100,000 UNITS/GM)TOPICALPOWDERTrueAT2004-07-15NYSTATIN
7ANDA065321_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALPOWDERFalse2006-08-18NYSTATIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101b44f91-9b68-464a-9693-b5d3e793bf3c (view SPL)Nyamyc (Nystatin Topical Powder, USP)prescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.2012-05-044008320465
21211504c-f89b-42ed-9d7a-2e1a658a9ccf (view SPL)NYSTATIN TOPICAL POWDER, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-09-261422540303
3656fc23b-65af-465e-9bcb-67fbbfa9b84e (view SPL)NYSTATIN TOPICAL POWDER, USPprescriptionHuman PrescriptionMayne Pharma Inc.MANUFACTURE2009-08-312683080152
49e122c5f-65e4-4c92-aaa0-ae97dd725b1a (view SPL)NYSTATIN TOPICAL POWDER, USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2012-10-191765191007
5a6f88015-4cac-4cb2-9012-92cc5390b5df (view SPL)Rx Only. FOR TOPICAL USE ONLY.Not for Ophthalmic Use.prescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2014-08-047398223015
6ce5a8256-ff1b-45eb-b1cf-c863cdff97c5 (view SPL)NYSTATIN TOPICAL POWDER, USPprescriptionHuman PrescriptionMajor2015-02-131009046456
7cf863efe-53d7-4654-94fc-6530ecdff921 (view SPL)NYSTATIN TOPICAL POWDER, USPprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2014-09-261433860530
8d62d9d90-3ef2-4697-b6d5-bdb892394998 (view SPL)Nystop Nystatin Topical Powder USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-08-251548685216
9e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f (view SPL)Nystop Nystatin Topical Powder, USP Rx Only For topical use only.Not for ophthalmic use.prescriptionHuman PrescriptionPaddock Laboratories, LlcMANUFACTURE2014-09-176005742008
10f64aacd0-4d8b-4a21-bfcb-8eb183bc6d86 (view SPL)Rx Only. FOR TOPICAL USE ONLY.Not for Ophthalmic Use.prescriptionHuman PrescriptionVensun Pharmaceuticals, Inc.MANUFACTURE2014-07-317425430052

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