Nystatin Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2013-10-15)
Oldest Current Product
1984-01-16
License(s)
ANDA
RxNORM
ORAL TABLET\NYSTATIN
FDAOB
ORAL\TABLET\NYSTATIN
SPL Active
ORAL\TABLET, COATED\NYSTATIN
ORAL\TABLET, FILM COATED\NYSTATIN
SPL Moiety
ORAL\TABLET, COATED\NYSTATIN
ORAL\TABLET, FILM COATED\NYSTATIN

product(s) by strength(s)

nystatin 500000 unt oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930983ANDATeva Pharmaceuticals Usa Inc1990-09-30NYSTATINORALTABLET, FILM COATEDANDA062506f03b294d-10cd-4bba-92c8-42ae9b110cd0
2231550051ANDAHeritage Pharmaceuticals Inc.2011-10-31NYSTATINORALTABLET, COATEDANDA062474e87b8480-987d-4f82-87bf-cf831d6984a1
3534890400ANDAMutual Pharmaceutical Company, Inc.1988-12-22NYSTATINORALTABLET, FILM COATEDANDA062838b70731df-fead-4f40-941e-7889a9c5d800

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1332610896ANDAAidarex Pharmaceuticals Llc1988-12-22NYSTATINORALTABLET, FILM COATED534890400ANDA0628387e072c84-5639-424c-9b44-2358f6b9081b
2422910651ANDAAvkare, Inc.2014-01-20NYSTATINORALTABLET, FILM COATED000930983ANDA0625068fd35f97-5405-2160-ca0f-35034ecd5a92
3551548252ANDACardinal Health1984-01-16NYSTATINORALTABLET, FILM COATED000930983ANDA062506b2053672-3a1b-452d-9146-f4d795d82785
4681511487ANDACarilion Materials Management1990-09-30NYSTATINORALTABLET, FILM COATED000930983ANDA062506fc0cc939-3ad1-47f2-87b9-cdd91712e0db

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060574MYCOSTATINTrueDELCOR ASSET CORPANDA060574_001
2ANDA061151NILSTATTrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA061151_001
3ANDA062065NYSTATINTrueSANDOZ INCANDA062065_001
4ANDA062402NYSTATINTrueWATSON LABORATORIES INC1982-12-16ANDA062402_001
5ANDA062474NYSTATINHERITAGE PHARMACEUTICALS INC1983-12-22ANDA062474_001
6ANDA062506NYSTATINTEVA PHARMACEUTICALS USA INC1984-01-16ANDA062506_001
7ANDA062524NYSTATINTrueUSL PHARMA INC1985-11-26ANDA062524_001
8ANDA062525NYSTATINTrueQUANTUM PHARMICS LTD1984-10-29ANDA062525_001
9ANDA062838NYSTATINMUTUAL PHARMACEUTICAL CO INC1988-12-22ANDA062838_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060574_001discontinuedNYSTATIN (500,000 UNITS)ORALTABLETFalseMYCOSTATIN
2ANDA061151_001discontinuedNYSTATIN (500,000 UNITS)ORALTABLETFalseNILSTAT
3ANDA062065_001discontinuedNYSTATIN (500,000 UNITS)ORALTABLETFalseNYSTATIN
4ANDA062402_001discontinuedNYSTATIN (500,000 UNITS)ORALTABLETFalse1982-12-16NYSTATIN
5ANDA062474_001RXNYSTATIN (500,000 UNITS)ORALTABLETFalseAA1983-12-22NYSTATIN
6ANDA062506_001RXNYSTATIN (500,000 UNITS)ORALTABLETTrueAA1984-01-16NYSTATIN
7ANDA062524_001discontinuedNYSTATIN (500,000 UNITS)ORALTABLETFalse1985-11-26NYSTATIN
8ANDA062525_001discontinuedNYSTATIN (500,000 UNITS)ORALTABLETFalse1984-10-29NYSTATIN
9ANDA062838_001RXNYSTATIN (500,000 UNITS)ORALTABLETFalseAA1988-12-22NYSTATIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17e072c84-5639-424c-9b44-2358f6b9081b (view SPL)NYSTATIN TABLETS USP (oral)prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-201332610896
28fd35f97-5405-2160-ca0f-35034ecd5a92 (view SPL)NYSTATIN TABLETS USPRx onlyprescriptionHuman PrescriptionAvkare, Inc.2014-01-201422910651
3b2053672-3a1b-452d-9146-f4d795d82785 (view SPL)NYSTATIN TABLETS USP0983prescriptionHuman PrescriptionCardinal HealthREPACK2011-06-102551548252
4b70731df-fead-4f40-941e-7889a9c5d800 (view SPL)NYSTATIN TABLETS USP (oral)prescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2015-01-083534890400
5e87b8480-987d-4f82-87bf-cf831d6984a1 (view SPL)NYSTATIN TABLETS, USP ( Oral)prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2013-11-273231550051
6f03b294d-10cd-4bba-92c8-42ae9b110cd0 (view SPL)NYSTATIN TABLETS USP0983Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-10-155000930983
7fc0cc939-3ad1-47f2-87b9-cdd91712e0db (view SPL)NYSTATIN TABLETS USP 0983 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-10-153681511487

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