Stavudine Oral Capsule

Brand(s)
Zerit
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-09-15)
Oldest Current Product
1994-06-24
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\STAVUDINE
FDAOB
ORAL\CAPSULE\STAVUDINE
SPL Active
ORAL\CAPSULE, GELATIN COATED\STAVUDINE
ORAL\CAPSULE\STAVUDINE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\STAVUDINE
ORAL\CAPSULE\STAVUDINE

product(s) by strength(s)

stavudine 15 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000031964ZeritNDAE.R. Squibb & Sons, L.L.C.1994-06-24STAVUDINEORALCAPSULE, GELATIN COATEDNDA0204127745cad8-720d-4755-87c7-9147c0915b0f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785040ANDAMylan Pharmaceuticals Inc.2011-08-24STAVUDINEORALCAPSULEANDA0790694794e7be-fb7b-d396-aeb3-9939b7f57987
2317220515ANDACamber Pharmaceuticals, Inc.2008-12-29STAVUDINEORALCAPSULEANDA07895712cbb604-d5f8-49ee-962c-bb12f4105bb3
3658620111ANDAAurobindo Pharma Limited2008-12-29STAVUDINEORALCAPSULEANDA077672d19c57bd-56f8-4640-b891-18f9c365e372

stavudine 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000031965ZeritNDAE.R. Squibb & Sons, L.L.C.1994-06-24STAVUDINEORALCAPSULE, GELATIN COATEDNDA0204127745cad8-720d-4755-87c7-9147c0915b0f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785041ANDAMylan Pharmaceuticals Inc.2011-08-24STAVUDINEORALCAPSULEANDA0790694794e7be-fb7b-d396-aeb3-9939b7f57987
2317220516ANDACamber Pharmaceuticals, Inc.2008-12-29STAVUDINEORALCAPSULEANDA07895712cbb604-d5f8-49ee-962c-bb12f4105bb3
3658620112ANDAAurobindo Pharma Limited2008-12-29STAVUDINEORALCAPSULEANDA077672d19c57bd-56f8-4640-b891-18f9c365e372

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080656ZeritNDAState Of Florida Doh Central Pharmacy2009-07-01STAVUDINEORALCAPSULE, GELATIN COATED000031965NDA0204128bb73c56-74cb-4602-b9a3-57bd1082b434
2538080852ANDAState Of Florida Doh Central Pharmacy2013-01-01STAVUDINEORALCAPSULE003785041ANDA0790697501de1e-149d-405e-94f6-da4010952adf

stavudine 30 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000031966ZeritNDAE.R. Squibb & Sons, L.L.C.1994-06-24STAVUDINEORALCAPSULE, GELATIN COATEDNDA0204127745cad8-720d-4755-87c7-9147c0915b0f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785042ANDAMylan Pharmaceuticals Inc.2011-08-24STAVUDINEORALCAPSULEANDA0790694794e7be-fb7b-d396-aeb3-9939b7f57987
2317220517ANDACamber Pharmaceuticals, Inc.2008-12-29STAVUDINEORALCAPSULEANDA07895712cbb604-d5f8-49ee-962c-bb12f4105bb3
3658620046ANDAAurobindo Pharma Limited2008-12-29STAVUDINEORALCAPSULEANDA077672d19c57bd-56f8-4640-b891-18f9c365e372

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080657ZeritNDAState Of Florida Doh Central Pharmacy2009-07-01STAVUDINEORALCAPSULE, GELATIN COATED000031966NDA0204128bb73c56-74cb-4602-b9a3-57bd1082b434

stavudine 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000031967ZeritNDAE.R. Squibb & Sons, L.L.C.1994-06-24STAVUDINEORALCAPSULE, GELATIN COATEDNDA0204127745cad8-720d-4755-87c7-9147c0915b0f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785043ANDAMylan Pharmaceuticals Inc.2011-08-24STAVUDINEORALCAPSULEANDA0790694794e7be-fb7b-d396-aeb3-9939b7f57987
2317220518ANDACamber Pharmaceuticals, Inc.2008-12-29STAVUDINEORALCAPSULEANDA07895712cbb604-d5f8-49ee-962c-bb12f4105bb3
3658620047ANDAAurobindo Pharma Limited2008-12-29STAVUDINEORALCAPSULEANDA077672d19c57bd-56f8-4640-b891-18f9c365e372

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790028ANDAKaiser Foundations Hospitals2010-01-27STAVUDINEORALCAPSULE317220518ANDA0789576d397a2a-06fc-467e-b014-c19e6384c8d9
2493490066ANDARemedyrepack Inc.2010-11-11STAVUDINEORALCAPSULE658620047ANDA077672e29485f8-df97-47b2-b5f9-62e99adcf4af
3538080594ANDAState Of Florida Doh Central Pharmacy2009-07-01STAVUDINEORALCAPSULE003785043ANDA079069752d2c13-5ca5-40b3-b066-55a9b6b1287a
4538080595ANDAState Of Florida Doh Central Pharmacy2009-07-01STAVUDINEORALCAPSULE317220518ANDA078957081991e0-eee4-4fa3-ac3d-0c32cb03e7f3
5538080795ZeritNDAState Of Florida Doh Central Pharmacy2009-07-01STAVUDINEORALCAPSULE, GELATIN COATED000031967NDA0204128bb73c56-74cb-4602-b9a3-57bd1082b434

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077672STAVUDINEAUROBINDO PHARMA LTD2008-12-29ANDA077672_001, ANDA077672_002, ANDA077672_003, ANDA077672_004
2ANDA078775STAVUDINEMATRIX LABORATORIES LTD2009-01-05ANDA078775_001, ANDA078775_002
3ANDA078957STAVUDINEHETERO LABS LTD UNIT III2008-12-29ANDA078957_001, ANDA078957_002, ANDA078957_003, ANDA078957_004
4ANDA079069STAVUDINEMYLAN PHARMACEUTICALS INC2008-12-29ANDA079069_001, ANDA079069_002, ANDA079069_003, ANDA079069_004
5NDA020412ZERITBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE1994-06-24NDA020412_001, NDA020412_002, NDA020412_003, NDA020412_004, NDA020412_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077672_001RXSTAVUDINE (30MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
2ANDA077672_002RXSTAVUDINE (40MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
3ANDA077672_003RXSTAVUDINE (15MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
4ANDA077672_004RXSTAVUDINE (20MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
5ANDA078775_001RXSTAVUDINE (30MG)ORALCAPSULEFalseAB2009-01-05STAVUDINE
6ANDA078775_002RXSTAVUDINE (40MG)ORALCAPSULEFalseAB2009-01-05STAVUDINE
7ANDA078957_001RXSTAVUDINE (15MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
8ANDA078957_002RXSTAVUDINE (20MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
9ANDA078957_003RXSTAVUDINE (30MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
10ANDA078957_004RXSTAVUDINE (40MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
11ANDA079069_001RXSTAVUDINE (15MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
12ANDA079069_002RXSTAVUDINE (20MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
13ANDA079069_003RXSTAVUDINE (30MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
14ANDA079069_004RXSTAVUDINE (40MG)ORALCAPSULEFalseAB2008-12-29STAVUDINE
15NDA020412_001discontinuedSTAVUDINE (5MG)ORALCAPSULEFalse1994-06-24ZERIT
16NDA020412_002RXSTAVUDINE (15MG)ORALCAPSULEFalseAB1994-06-24ZERIT
17NDA020412_003RXSTAVUDINE (20MG)ORALCAPSULEFalseAB1994-06-24ZERIT
18NDA020412_004RXSTAVUDINE (30MG)ORALCAPSULEFalseAB1994-06-24ZERIT
19NDA020412_005RXSTAVUDINE (40MG)ORALCAPSULETrueAB1994-06-24ZERIT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1081991e0-eee4-4fa3-ac3d-0c32cb03e7f3 (view SPL)prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-081538080595
212cbb604-d5f8-49ee-962c-bb12f4105bb3 (view SPL)prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.analysis, manufacture2009-07-202317220515, 317220516, 317220517, 317220518
34794e7be-fb7b-d396-aeb3-9939b7f57987 (view SPL)These highlights do not include all the information needed to use STAVUDINE CAPSULES safely and effectively. See full prescribing information for STAVUDINE CAPSULES. STAVUDINE capsules, for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-10-147003785040, 003785041, 003785042, 003785043
46d397a2a-06fc-467e-b014-c19e6384c8d9 (view SPL)prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-03-081001790028
57501de1e-149d-405e-94f6-da4010952adf (view SPL)These highlights do not include all the information needed to use stavudine safely and effectively. See full prescribing information for stavudine capsules. Stavudine Capsules, USP Initial U.S. Approval: 1994prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-09-301538080852
6752d2c13-5ca5-40b3-b066-55a9b6b1287a (view SPL)prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-081538080594
77745cad8-720d-4755-87c7-9147c0915b0f (view SPL)These highlights do not include all the information needed to use ZERIT safely and effectively. See full prescribing information for ZERIT. ZERIT (stavudine) CapsulesZERIT (stavudine) for Oral SolutionInitial U.S. Approval: 1994prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-09-1523000031964, 000031965, 000031966, 000031967, 000031968Stavudine Oral Solution
88bb73c56-74cb-4602-b9a3-57bd1082b434 (view SPL)ZERIT (stavudine) CapsulesZERIT (stavudine) for Oral SolutionprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-08-123538080656, 538080657, 538080795
9d19c57bd-56f8-4640-b891-18f9c365e372 (view SPL)These highlights do not include all the information needed to use stavudine safely and effectively. See full prescribing information for stavudine capsules, USP.Stavudine Capsules, USPInitial U.S. Approval: 1994prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2013-08-238658620046, 658620047, 658620111, 658620112
10e29485f8-df97-47b2-b5f9-62e99adcf4af (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-11-1180493490066

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