Sulfasalazine Oral Tablet

Brand(s)
Azulfidine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-05-14)
Oldest Current Product
1950-06-20
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\SULFASALAZINE
FDAOB
ORAL\TABLET, DELAYED RELEASE\SULFASALAZINE
ORAL\TABLET\SULFASALAZINE
SPL Active
ORAL\TABLET\SULFASALAZINE
SPL Moiety
ORAL\TABLET\SULFASALAZINE

product(s) by strength(s)

sulfasalazine 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000130101AzulfidineNDAPharmacia And Upjohn Company1950-06-20SULFASALAZINEORALTABLETNDA007073ddbe69f3-bd55-45f3-a64f-f60226c744c4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910796ANDAWatson Laboratories, Inc.1982-10-01SULFASALAZINEORALTABLETANDA085828ad13d598-7b1b-48d3-a25b-08635b419f99
2006035801ANDAQualitest Pharmaceuticals2002-01-11SULFASALAZINEORALTABLETANDA0403493f915e6f-aa04-4ba6-8553-d443fb177d6d
3597625000NDA AUTHORIZED GENERICGreenstone Llc2003-07-01SULFASALAZINEORALTABLETNDA00707348fbc535-a33a-45ee-85ff-9d1ec9b31d9c

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009041152NDA AUTHORIZED GENERICMajor2000-08-18SULFASALAZINEORALTABLET597625000NDA021243ee7129fd-525b-4ed3-b8a6-e4587697f655
2687889021ANDAPreferred Pharmaceuticals, Inc.2010-06-09SULFASALAZINEORALTABLET005910796ANDA08719757d4e53a-d3d6-4f40-8e9b-04b34bd49156

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790174NDA AUTHORIZED GENERICKaiser Foundations Hospitals2015-04-07SULFASALAZINEORALTABLET597625000NDA00707342178f09-db8b-4cc5-b4f2-e4bb0d59fbbe
2105440288ANDABlenheim Pharmacal, Inc.2013-11-18SULFASALAZINEORALTABLET006035801ANDA0403490ff320ac-60e1-4b75-e054-00144ff88e88
3332610756ANDAAidarex Pharmaceuticals Llc2002-01-11SULFASALAZINEORALTABLET006035801ANDA0403492fc8c918-157c-4898-9b26-80d9ae2fc143
4433530495NDA AUTHORIZED GENERICAphena Pharma Solutions - Tennessee, Llc2003-07-01SULFASALAZINEORALTABLET597625000NDA007073a5a23c68-f5bd-42dd-b72c-0641659bae46
5493490067ANDARemedyrepack Inc.2010-11-15SULFASALAZINEORALTABLET005910796ANDA085828af712365-34ad-4a37-b35f-ec53e299534c
6493490178ANDARemedyrepack Inc.2011-04-19SULFASALAZINEORALTABLET005910796ANDA0858285cd02f3a-f953-4513-a63a-9c7e84d49f53
7493490832ANDARemedyrepack Inc.2011-12-01SULFASALAZINEORALTABLET006035801ANDA040349fdd469a2-5b62-4d80-8073-01f3e96ff55e
8500900086NDA AUTHORIZED GENERICA-S Medication Solutions Llc2003-07-01SULFASALAZINEORALTABLET597625000NDA00707332fd1726-ed81-4441-9594-3aecf2db1dbf
9502680730ANDAAvpak2014-01-14SULFASALAZINEORALTABLET005910796ANDA08582867dcfa7d-f656-6c92-60bb-4b40dcecf080
10521250411ANDARemedyrepack Inc.2013-05-15SULFASALAZINEORALTABLET005910796ANDA085828b9d255ad-6dbf-4bde-9dbb-07e5417f5457
11545690313NDA AUTHORIZED GENERICA-S Medication Solutions Llc2003-07-01SULFASALAZINEORALTABLET597625000NDA007073443ee6bb-2c03-4263-b960-d9e3d7381bcd
12552890176ANDAPd-Rx Pharmaceuticals, Inc.2002-01-11SULFASALAZINEORALTABLET006035801ANDA0403496e90e3e6-b4ee-42b3-9fdc-33ef333eb79a

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040349SULFASALAZINEVINTAGE PHARMACEUTICALS INC2002-01-11ANDA040349_001Sulfasalazine Delayed Release Oral Tablet
2ANDA075339SULFASALAZINEVINTAGE PHARMACEUTICALS INC2002-01-11ANDA075339_001Sulfasalazine Delayed Release Oral Tablet
3ANDA080197SULFASALAZINETrueHERITAGE PHARMACEUTICALS INCANDA080197_001Sulfasalazine Delayed Release Oral Tablet
4ANDA083450S.A.S.-500TrueSOLVAY PHARMACEUTICALSANDA083450_001Sulfasalazine Delayed Release Oral Tablet
5ANDA084964SULFASALAZINETrueWATSON LABORATORIES INCANDA084964_001Sulfasalazine Delayed Release Oral Tablet
6ANDA085828SULFASALAZINEWATSON LABORATORIES INCANDA085828_001Sulfasalazine Delayed Release Oral Tablet
7ANDA086184SULFASALAZINETrueSANDOZ INCANDA086184_001Sulfasalazine Delayed Release Oral Tablet
8ANDA087197SULFASALAZINETrueWATSON LABORATORIES INCANDA087197_001Sulfasalazine Delayed Release Oral Tablet
9ANDA088052SULFASALAZINETrueWATSON LABORATORIES INC1983-05-24ANDA088052_001Sulfasalazine Delayed Release Oral Tablet
10ANDA089339SULFASALAZINETrueSUPERPHARM CORP1987-10-26ANDA089339_001Sulfasalazine Delayed Release Oral Tablet
11ANDA089590SULFASALAZINETrueMUTUAL PHARMACEUTICAL CO INC1987-10-19ANDA089590_001Sulfasalazine Delayed Release Oral Tablet
12NDA007073AZULFIDINEPHARMACIA AND UPJOHN CONDA007073_001, NDA007073_002Sulfasalazine Delayed Release Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040349_001RXSULFASALAZINE (500MG)ORALTABLETFalseAB2002-01-11SULFASALAZINE
2ANDA075339_001RXSULFASALAZINE (500MG)ORALTABLET, DELAYED RELEASEFalseAB2002-01-11SULFASALAZINE
3ANDA080197_001discontinuedSULFASALAZINE (500MG)ORALTABLETFalseSULFASALAZINE
4ANDA083450_001discontinuedSULFASALAZINE (500MG)ORALTABLETFalseS.A.S.-500
5ANDA084964_001discontinuedSULFASALAZINE (500MG)ORALTABLETFalseSULFASALAZINE
6ANDA085828_001RXSULFASALAZINE (500MG)ORALTABLETFalseABSULFASALAZINE
7ANDA086184_001discontinuedSULFASALAZINE (500MG)ORALTABLETFalseSULFASALAZINE
8ANDA087197_001discontinuedSULFASALAZINE (500MG)ORALTABLETFalseSULFASALAZINE
9ANDA088052_001discontinuedSULFASALAZINE (500MG)ORALTABLET, DELAYED RELEASEFalse1983-05-24SULFASALAZINE
10ANDA089339_001discontinuedSULFASALAZINE (500MG)ORALTABLETFalse1987-10-26SULFASALAZINE
11ANDA089590_001discontinuedSULFASALAZINE (500MG)ORALTABLETFalse1987-10-19SULFASALAZINE
12NDA007073_001RXSULFASALAZINE (500MG)ORALTABLETTrueABAZULFIDINE
13NDA007073_002RXSULFASALAZINE (500MG)ORALTABLET, DELAYED RELEASETrueAB1983-04-06AZULFIDINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10ff320ac-60e1-4b75-e054-00144ff88e88 (view SPL)SULFASALAZINE TABLETS, USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-02-251105440288
22fc8c918-157c-4898-9b26-80d9ae2fc143 (view SPL)SULFASALAZINE TABLETS, USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-02-011332610756
332fd1726-ed81-4441-9594-3aecf2db1dbf (view SPL)Sulfasalazine Tablets, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900086
43f915e6f-aa04-4ba6-8553-d443fb177d6d (view SPL)SULFASALAZINE TABLETS, USPprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2014-04-0210006035801
542178f09-db8b-4cc5-b4f2-e4bb0d59fbbe (view SPL)Sulfasalazine Tablets, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2015-04-173001790174
6443ee6bb-2c03-4263-b960-d9e3d7381bcd (view SPL)Sulfasalazine Tablets, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-171545690313
748fbc535-a33a-45ee-85ff-9d1ec9b31d9c (view SPL)Sulfasalazine Tablets, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-03-1110597625000
857d4e53a-d3d6-4f40-8e9b-04b34bd49156 (view SPL)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.repack2011-06-131687889021
95cd02f3a-f953-4513-a63a-9c7e84d49f53 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-191493490178
1067dcfa7d-f656-6c92-60bb-4b40dcecf080 (view SPL)Sulfasalazine Tablets USP Revised: December 2012 Rx onlyprescriptionHuman PrescriptionAvpak2014-10-222502680730
116e90e3e6-b4ee-42b3-9fdc-33ef333eb79a (view SPL)SULFASALAZINE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-03-093552890176
12a5a23c68-f5bd-42dd-b72c-0641659bae46 (view SPL)Sulfasalazine Tablets, USPprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-07-031433530495
13ad13d598-7b1b-48d3-a25b-08635b419f99 (view SPL)Sulfasalazine Tablets USP Revised: December 2012 Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-03-259005910796
14af712365-34ad-4a37-b35f-ec53e299534c (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-11-1581493490067
15b9d255ad-6dbf-4bde-9dbb-07e5417f5457 (view SPL)SulfasalazineTablets USPRevised: December 2012Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-151521250411
16ddbe69f3-bd55-45f3-a64f-f60226c744c4 (view SPL)Azulfidine sulfasalazine tablets, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-05-1412000130101
17ee7129fd-525b-4ed3-b8a6-e4587697f655 (view SPL)Sulfasalazine Tablets, USPprescriptionHuman PrescriptionMajorRELABEL, REPACK2011-03-303009041152
18fdd469a2-5b62-4d80-8073-01f3e96ff55e (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-12-011493490832

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