Sulfasalazine Delayed Release 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
DELAYED RELEASE ORAL TABLET\SULFASALAZINE
FDAOB
ORAL\TABLET, DELAYED RELEASE\SULFASALAZINE
ORAL\TABLET\SULFASALAZINE
SPL Active
ORAL\TABLET, DELAYED RELEASE\SULFASALAZINE
SPL Moiety
ORAL\TABLET, DELAYED RELEASE\SULFASALAZINE

product(s) by strength(s)

sulfasalazine 500 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000130102AzulfidineNDAPharmacia And Upjohn Company1950-06-20SULFASALAZINEORALTABLET, DELAYED RELEASENDA007073b9ef541a-93c8-4428-ba45-398aa0b327d1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006035803ANDAQualitest Pharmaceuticals2002-01-11SULFASALAZINEORALTABLET, DELAYED RELEASEANDA075339599be7ea-4036-4e43-a411-1c42369b1b8c
2597620104NDA AUTHORIZED GENERICGreenstone Llc2005-05-05SULFASALAZINEORALTABLET, DELAYED RELEASENDA007073257cee60-b68f-4c2b-b57d-8e4d73d17e09

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040349SULFASALAZINEVINTAGE PHARMACEUTICALS INC2002-01-11ANDA040349_001Sulfasalazine Oral Tablet
2ANDA075339SULFASALAZINEVINTAGE PHARMACEUTICALS INC2002-01-11ANDA075339_001Sulfasalazine Oral Tablet
3ANDA080197SULFASALAZINETrueHERITAGE PHARMACEUTICALS INCANDA080197_001Sulfasalazine Oral Tablet
4ANDA083450S.A.S.-500TrueSOLVAY PHARMACEUTICALSANDA083450_001Sulfasalazine Oral Tablet
5ANDA084964SULFASALAZINETrueWATSON LABORATORIES INCANDA084964_001Sulfasalazine Oral Tablet
6ANDA085828SULFASALAZINEWATSON LABORATORIES INCANDA085828_001Sulfasalazine Oral Tablet
7ANDA086184SULFASALAZINETrueSANDOZ INCANDA086184_001Sulfasalazine Oral Tablet
8ANDA087197SULFASALAZINETrueWATSON LABORATORIES INCANDA087197_001Sulfasalazine Oral Tablet
9ANDA088052SULFASALAZINETrueWATSON LABORATORIES INC1983-05-24ANDA088052_001Sulfasalazine Oral Tablet
10ANDA089339SULFASALAZINETrueSUPERPHARM CORP1987-10-26ANDA089339_001Sulfasalazine Oral Tablet
11ANDA089590SULFASALAZINETrueMUTUAL PHARMACEUTICAL CO INC1987-10-19ANDA089590_001Sulfasalazine Oral Tablet
12NDA007073AZULFIDINEPHARMACIA AND UPJOHN CONDA007073_001, NDA007073_002Sulfasalazine 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)
1257cee60-b68f-4c2b-b57d-8e4d73d17e09 (view SPL)Sulfasalazine Delayed Release Tablets, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-03-1111597620104
2599be7ea-4036-4e43-a411-1c42369b1b8c (view SPL)SulfasalazineDelayed-Release Tablets, USPprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, MANUFACTURE2014-03-2910006035803
3b9ef541a-93c8-4428-ba45-398aa0b327d1 (view SPL)Azulfidine EN-tabs sulfasalazine delayed release tablets, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-05-1411000130102

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