Nystatin Topical Ointment

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. (2012-04-02)
Oldest Current Product
1982-09-23
License(s)
ANDA
RxNORM
TOPICAL OINTMENT\NYSTATIN
FDAOB
TOPICAL\OINTMENT\NYSTATIN
SPL Active
TOPICAL\OINTMENT\NYSTATIN
SPL Moiety
TOPICAL\OINTMENT\NYSTATIN

product(s) by strength(s)

nystatin 100 unt/mg topical ointment

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680007ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1982-09-23NYSTATINTOPICALOINTMENTANDA06212401777cce-37ea-499c-ab13-82041a37ccfc
2004720166ANDAActavis Pharma, Inc.2002-09-03NYSTATINTOPICALOINTMENTANDA062840aee7ce4c-8cc6-4446-a4d7-63bc4773066f
3458020048ANDAPerrigo New York Inc2006-09-15NYSTATINTOPICALOINTMENTANDA0624726c091c66-2e4d-4412-b7bf-35315dc8152f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540284ANDARebel Distributors Corp1982-09-23NYSTATINTOPICALOINTMENT001680007ANDA062124da4cd3fc-906d-4468-b7f9-c20f085c95ed
2532170022ANDAAidarex Pharmaceuticals Llc2002-09-03NYSTATINTOPICALOINTMENT004720166ANDA062840aae5b1f0-f852-4b64-a5ef-6f8334ae2b4d
3545691104ANDAA-S Medication Solutions Llc2006-09-15NYSTATINTOPICALOINTMENT458020048ANDA062472cd05a359-bec5-4d10-a8bd-e2351600b72a
4548681425ANDAPhysicians Total Care, Inc.2007-04-11NYSTATINTOPICALOINTMENT001680007ANDA062124db8e62a1-9a5e-49d1-8c6b-64a3e083487c
5631870464ANDAProficient Rx Lp2002-09-03NYSTATINTOPICALOINTMENT004720166ANDA062840d7d04c02-d07d-4382-8f93-5c0c3e68790c
6687889516ANDAPreferred Pharmaceuticals, Inc.2014-02-10NYSTATINTOPICALOINTMENT458020048ANDA062472d00a5f80-aa50-4b0b-82d2-63ba33a56b2f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060571MYCOSTATINTrueDELCOR ASSET CORPANDA060571_001
2ANDA061444NILSTATTrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA061444_001
3ANDA062124NYSTATINFOUGERA PHARMACEUTICALS INC1982-09-23ANDA062124_002
4ANDA062472NYSTATINPERRIGO NEW YORK INC1984-02-13ANDA062472_001
5ANDA062731MYKINACTrueALPHARMA US PHARMACEUTICALS DIVISION1986-09-22ANDA062731_001
6ANDA062840NYSTATINACTAVIS MID ATLANTIC LLC1987-11-13ANDA062840_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060571_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalseMYCOSTATIN
2ANDA061444_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalseNILSTAT
3ANDA062124_002RXNYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTTrueAT1982-09-23NYSTATIN
4ANDA062472_001RXNYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalseAT1984-02-13NYSTATIN
5ANDA062731_001discontinuedNYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalse1986-09-22MYKINAC
6ANDA062840_001RXNYSTATIN (100,000 UNITS/GM)TOPICALOINTMENTFalseAT1987-11-13NYSTATIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101777cce-37ea-499c-ab13-82041a37ccfc (view SPL)NYSTATIN OINTMENT USPprescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2012-04-024001680007
26c091c66-2e4d-4412-b7bf-35315dc8152f (view SPL)NYSTATIN OINTMENT USPprescriptionHuman PrescriptionPerrigo New York Inc2015-10-025458020048
3aae5b1f0-f852-4b64-a5ef-6f8334ae2b4d (view SPL)NYSTATIN OINTMENT USP (100,000 units/g)prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-10-021532170022
4aee7ce4c-8cc6-4446-a4d7-63bc4773066f (view SPL)NYSTATIN OINTMENT USP (100,000 units/g)prescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2006-01-072004720166
5cd05a359-bec5-4d10-a8bd-e2351600b72a (view SPL)NYSTATIN OINTMENT USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545691104
6d00a5f80-aa50-4b0b-82d2-63ba33a56b2f (view SPL)NYSTATIN OINTMENT USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-11-132687889516
7d7d04c02-d07d-4382-8f93-5c0c3e68790c (view SPL)NYSTATIN OINTMENT USP (100,000 units/g)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870464
8da4cd3fc-906d-4468-b7f9-c20f085c95ed (view SPL)NYSTATIN OINTMENT USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-08-281422540284
9db8e62a1-9a5e-49d1-8c6b-64a3e083487c (view SPL)NYSTATIN OINTMENT USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-09-063548681425

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