Nystatin Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmaceutical Associates, Inc. (2013-12-05)
Oldest Current Product
1984-06-07
License(s)
ANDA
RxNORM
ORAL SUSPENSION\NYSTATIN
FDAOB
ORAL\SUSPENSION\NYSTATIN
SPL Active
ORAL\SUSPENSION\NYSTATIN
SPL Moiety
ORAL\SUSPENSION\NYSTATIN

product(s) by strength(s)

nystatin 100000 unt/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001214785ANDAPharmaceutical Associates, Inc.2009-06-01NYSTATINORALSUSPENSIONANDA0625128e451863-6c53-4069-bc0f-71224356bfcb
2001680037ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1984-06-07NYSTATINORALSUSPENSIONANDA062517855277ef-d6ad-4582-a289-c8c739bf675b
3006031481ANDAQualitest Pharmaceuticals2005-06-28NYSTATINORALSUSPENSIONANDA065148ac2bbe44-79e5-430d-b1c3-b2a565964c3e
4503830587ANDAHi-Tech Pharmacal Co., Inc.2012-01-27NYSTATINORALSUSPENSIONANDA06404241c75856-4e15-4397-a6d4-c1193c0eb0e7
5516724117ANDATaro Pharmaceuticals U.S.A., Inc.1988-02-29NYSTATINORALSUSPENSIONANDA06287601c469b3-ec10-452c-8c02-3e7d22e40297
6604320537ANDAMorton Grove Pharmaceuticals, Inc.1995-04-15NYSTATINORALSUSPENSIONANDA062512d468395c-0f4c-4503-9a39-ae847524e683
7666890008ANDAVistapharm Inc.2012-05-01NYSTATINORALSUSPENSIONANDA0654223651ad5b-436c-4ae9-9ab1-80b6ac8ae0a8
8666890037ANDAVistapharm Inc.2010-05-10NYSTATINORALSUSPENSIONANDA06414241034d7b-33a1-4d6d-b425-9cfefff8d518

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900174ANDAStat Rx Usa Llc2005-06-28NYSTATINORALSUSPENSION006031481ANDA0651484c25ae58-c424-44c1-85e0-63b99ecd2ecb
2216950643ANDARebel Distributors Corp2005-06-28NYSTATINORALSUSPENSION006031481ANDA06514829ccf947-91c1-405a-aba6-5889e3c75d70
3422540067ANDARebel Distributors Corp1995-04-15NYSTATINORALSUSPENSION604320537ANDA062512ceb0fc2d-9039-4961-84b6-ceb2a2649c50
4422540322ANDARebel Distributors Corp2012-01-27NYSTATINORALSUSPENSION503830587ANDA0640428ce02e76-303c-4e06-a47e-0a7bbf46c3f2
5545691018ANDAA-S Medication Solutions Llc1988-02-29NYSTATINORALSUSPENSION516724117ANDA062876e73d7b8f-1a19-4ac4-a9d3-00c5d1c6b626
6548680243ANDAPhysicians Total Care, Inc.1994-03-28NYSTATINORALSUSPENSION604320537ANDA062512f7a98d15-ce46-4358-ac6e-d10afa4d34c2
7551541578ANDACardinal Health2005-12-15NYSTATINORALSUSPENSION680940599ANDA0625124c71071e-6c9f-4059-ba3f-b9c3aa643452
8551544056ANDACardinal Health2010-05-10NYSTATINORALSUSPENSION666890037ANDA064142ba531b47-6a96-432b-ae01-6d8e18634463
9551549436ANDACardinal Health2009-06-01NYSTATINORALSUSPENSION001214785ANDA0625126976788c-b2fa-4bcc-ada0-4ae589ff5634
10636292598ANDABryant Ranch Prepack1995-04-15NYSTATINORALSUSPENSION604320537ANDA062512ad654253-6787-4ee6-9991-de197d3a0b6a
11637390634ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation1995-04-15NYSTATINORALSUSPENSION604320537ANDA0625124481429a-88bc-418a-9e87-ac3ec0a9a80f
12680940599ANDAPrecision Dose Inc.2005-12-15NYSTATINORALSUSPENSION604320537ANDA06251229a5391d-6db4-4226-82ed-4481b3e445c8
13687889072ANDAPreferred Pharmaceuticals, Inc.2005-06-28NYSTATINORALSUSPENSION006031481ANDA065148c808de10-d308-4687-8af3-9e428b7fad8c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA061533MYCOSTATINTrueDELCOR ASSET CORPANDA061533_001
2ANDA062349NYSTATING AND W LABORATORIES INC1982-07-14ANDA062349_001
3ANDA062512NYSTATINWOCKHARDT EU OPERATIONS (SWISS) AG1984-10-29ANDA062512_001
4ANDA062517NYSTATINE FOUGERA DIV ALTANA INC1984-06-07ANDA062517_001
5ANDA062518NYSTATINTruePHARMADERM DIV ALTANA INC1984-07-06ANDA062518_001
6ANDA062519NYSTEXTrueSAVAGE LABORATORIES INC DIV ALTANA INC1984-07-06ANDA062519_001
7ANDA062541NYSTATINTruePHARMAFAIR INC1985-01-16ANDA062541_001
8ANDA062571NYSTATINTrueALPHARMA US PHARMACEUTICALS DIVISION1985-10-29ANDA062571_001
9ANDA062670NYSTATINTrueTEVA PHARMACEUTICALS USA INC1987-06-18ANDA062670_001
10ANDA062776NYSTATINTrueG AND W LABORATORIES INC1987-12-17ANDA062776_001
11ANDA062832NYSTATINTrueROXANE LABORATORIES INC1991-12-27ANDA062832_001
12ANDA062835NYSTATINTrueMORTON GROVE PHARMACEUTICALS INC1987-11-19ANDA062835_001
13ANDA062876NYSTATINTARO PHARMACEUTICALS USA INC1988-02-29ANDA062876_001
14ANDA064042NYSTATINHI TECH PHARMACAL CO INC1994-02-28ANDA064042_001
15ANDA064142NYSTATINVISTAPHARM INC1998-06-25ANDA064142_001
16ANDA065148NYSTATINVINTAGE PHARMACEUTICALS INC2005-06-28ANDA065148_001
17ANDA065422NYSTATINVISTAPHARM INC2011-03-07ANDA065422_001
18NDA050299NILSTATTrueGLENMARK GENERICS INC USANDA050299_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA061533_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseMYCOSTATIN
2ANDA062349_001RXNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseAA1982-07-14NYSTATIN
3ANDA062512_001RXNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONTrueAA1984-10-29NYSTATIN
4ANDA062517_001RXNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseAA1984-06-07NYSTATIN
5ANDA062518_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalse1984-07-06NYSTATIN
6ANDA062519_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalse1984-07-06NYSTEX
7ANDA062541_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalse1985-01-16NYSTATIN
8ANDA062571_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalse1985-10-29NYSTATIN
9ANDA062670_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalse1987-06-18NYSTATIN
10ANDA062776_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalse1987-12-17NYSTATIN
11ANDA062832_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalse1991-12-27NYSTATIN
12ANDA062835_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalse1987-11-19NYSTATIN
13ANDA062876_001RXNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseAA1988-02-29NYSTATIN
14ANDA064042_001RXNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseAA1994-02-28NYSTATIN
15ANDA064142_001RXNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseAA1998-06-25NYSTATIN
16ANDA065148_001RXNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseAA2005-06-28NYSTATIN
17ANDA065422_001RXNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseAA2011-03-07NYSTATIN
18NDA050299_001discontinuedNYSTATIN (100,000 UNITS/ML)ORALSUSPENSIONFalseNILSTAT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101c469b3-ec10-452c-8c02-3e7d22e40297 (view SPL)Nystatin Oral Suspension, USPprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2011-08-082516724117
229a5391d-6db4-4226-82ed-4481b3e445c8 (view SPL)NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)prescriptionHuman PrescriptionPrecision Dose Inc.2012-02-172680940599
329ccf947-91c1-405a-aba6-5889e3c75d70 (view SPL)NYSTATIN ORAL SUSPENSION, USP 100,000 units per mLprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-031216950643
43651ad5b-436c-4ae9-9ab1-80b6ac8ae0a8 (view SPL)NYSTATIN ORAL SUSPENSION, USPprescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE2012-04-182666890008
541034d7b-33a1-4d6d-b425-9cfefff8d518 (view SPL)NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mLprescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE2012-08-303666890037
641c75856-4e15-4397-a6d4-c1193c0eb0e7 (view SPL)Nystatin Oral Suspension, USP100,000 units per mLprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2012-01-272503830587
74481429a-88bc-418a-9e87-ac3ec0a9a80f (view SPL)NYSTATIN ORAL SUSPENSION, USPprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2015-03-241637390634
84c25ae58-c424-44c1-85e0-63b99ecd2ecb (view SPL)NYSTATIN ORAL SUSPENSION, USP 100,000 units per mLprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-07-181165900174
94c71071e-6c9f-4059-ba3f-b9c3aa643452 (view SPL)NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)prescriptionHuman PrescriptionCardinal HealthREPACK2011-05-251551541578
106976788c-b2fa-4bcc-ada0-4ae589ff5634 (view SPL)Nystatin Oral Suspension USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-01-294551549436
11855277ef-d6ad-4582-a289-c8c739bf675b (view SPL)Nystatin Oral Suspension, USPprescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2012-07-122001680037
128ce02e76-303c-4e06-a47e-0a7bbf46c3f2 (view SPL)Nystatin Oral Suspension, USP100,000 units per mLprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-10-161422540322
138e451863-6c53-4069-bc0f-71224356bfcb (view SPL)Nystatin Oral Suspension USPprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE, REPACK2013-12-052001214785
14ac2bbe44-79e5-430d-b1c3-b2a565964c3e (view SPL)NYSTATIN ORAL SUSPENSION, USP 100,000 units per mLprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-04-206006031481
15ad654253-6787-4ee6-9991-de197d3a0b6a (view SPL)NYSTATIN ORAL SUSPENSION, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-04-251000636292598
16ba531b47-6a96-432b-ae01-6d8e18634463 (view SPL)NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mLprescriptionHuman PrescriptionCardinal HealthREPACK2014-11-202551544056
17c808de10-d308-4687-8af3-9e428b7fad8c (view SPL)NYSTATIN ORAL SUSPENSION, USP 100,000 units per mLprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-06-192687889072
18ceb0fc2d-9039-4961-84b6-ceb2a2649c50 (view SPL)NYSTATIN ORAL SUSPENSION, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-201422540067
19d468395c-0f4c-4503-9a39-ae847524e683 (view SPL)NYSTATIN ORAL SUSPENSION, USPprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.API MANUFACTURE2010-06-283604320537
20e73d7b8f-1a19-4ac4-a9d3-00c5d1c6b626 (view SPL)Nystatin Oral Suspension, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545691018
21f7a98d15-ce46-4358-ac6e-d10afa4d34c2 (view SPL)NYSTATIN ORAL SUSPENSION, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-06-281548680243

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