Zidovudine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription, Human Prescription with Highlights
Master SPL
Camber Pharmaceuticals, Inc. (2011-08-11)
Oldest Current Product
2005-09-19
License(s)
ANDA
RxNORM
ORAL TABLET\ZIDOVUDINE
FDAOB
ORAL\TABLET\ZIDOVUDINE
SPL Active
ORAL\TABLET, FILM COATED\ZIDOVUDINE
ORAL\TABLET\ZIDOVUDINE
SPL Moiety
ORAL\TABLET, FILM COATED\ZIDOVUDINE
ORAL\TABLET\ZIDOVUDINE

product(s) by strength(s)

zidovudine 300 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540052ANDARoxane Laboratories, Inc2005-09-19ZIDOVUDINEORALTABLETANDA076844d851ebb0-2370-4363-925c-628ba7fbc221
2003786106ANDAMylan Pharmaceuticals Inc.2008-12-19ZIDOVUDINEORALTABLET, FILM COATEDANDA078922cd3f2a72-3f01-49ba-9efe-9f2e6fedbd01
3005271905ANDALannett Company, Inc.2014-03-25ZIDOVUDINEORALTABLET, FILM COATEDANDA202058425faad5-8dbc-455b-a8c3-60bdf0e2ce54
4317220509ANDACamber Pharmaceuticals, Inc.2011-01-01ZIDOVUDINEORALTABLETANDA090092ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4
5523430045ANDALucid Pharma Llc2005-09-19ZIDOVUDINEORALTABLET, FILM COATEDANDA077267c2dbe442-bd0c-40bf-be76-b18595676dc2
6531040101ANDACipla Ltd.2010-10-27ZIDOVUDINEORALTABLET, FILM COATEDANDA09056129489c0e-e981-4bc0-beaf-05c9a9c55c1f
7658620024ANDAAurobindo Pharma Limited2005-09-19ZIDOVUDINEORALTABLET, FILM COATEDANDA077267e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950369ANDARebel Distributors Corp2009-07-01ZIDOVUDINEORALTABLET, FILM COATED658620024ANDA0772671b34c6ec-ac27-455e-976e-d22cf9d81950
2493490838ANDARemedyrepack Inc.2013-05-09, 2015-09-17, 2015-10-19ZIDOVUDINEORALTABLET317220509ANDA09009248b0c80a-33fd-431b-90ef-314a3834eae1, 86dccc6d-83f3-4934-8ffa-b2e92ea08f86, 8f13c494-6430-4e89-97d2-1becf12644c0
3493490867ANDARemedyrepack Inc.2013-04-15ZIDOVUDINEORALTABLET, FILM COATED658620024ANDA0772672c3264a4-1194-46a0-9343-927da4eda5b8, 5ac42750-b856-4f4f-bc05-2758c3035250, b3d75ea7-66d5-44e9-9251-0e5967e8501b, d41fdad8-c67a-4fc8-a775-5b5c41c0b0e7
4538080812ANDAState Of Florida Doh Central Pharmacy2009-07-01ZIDOVUDINEORALTABLET, FILM COATED658620024ANDA0772679a2c643d-5c5f-4427-804d-8b0eb9797157
5538080878ANDAState Of Florida Doh Central Pharmacy2013-01-01ZIDOVUDINEORALTABLET, FILM COATED003786106ANDA0789224ccc8192-fc3a-4671-a7ce-5565a7b5aaef
6617860305ANDARemedyrepack Inc.2015-05-19, 2015-05-26, 2015-06-17ZIDOVUDINEORALTABLET, FILM COATED005271905ANDA2020584825f6b6-b50d-4708-acaf-26ab529b6757, 5e0105d7-dc06-4797-b65b-d3ea5b33d2e7, bd5691b9-76fc-4322-a49d-18c96bc0182d
7636294144ANDABryant Ranch Prepack2005-09-19ZIDOVUDINEORALTABLET, FILM COATED658620024ANDA07726727370999-074b-4674-8655-e998419ec9d7
8680840462ANDAAmerican Health Packaging2011-01-03ZIDOVUDINEORALTABLET, FILM COATED658620024ANDA0772674ce97d53-e852-49ad-92e3-24031a115e26

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076844ZIDOVUDINEROXANE LABORATORIES INC2005-09-19ANDA076844_001
2ANDA077267ZIDOVUDINEAUROBINDO PHARMA LTD2005-09-19ANDA077267_001
3ANDA077327ZIDOVUDINETrueRANBAXY LABORATORIES LTD2005-09-19ANDA077327_001
4ANDA078922ZIDOVUDINEMYLAN PHARMACEUTICALS INC2008-02-14ANDA078922_001
5ANDA090092ZIDOVUDINEHETERO LABS LTD UNIT III2008-04-25ANDA090092_001
6ANDA090561ZIDOVUDINECIPLA LTD2010-10-27ANDA090561_001
7ANDA202058ZIDOVUDINESUNSHINE LAKE PHARMA CO LTD2011-10-07ANDA202058_001
8NDA020518RETROVIRTrueVIIV HEALTHCARE CO1995-12-19NDA020518_001, NDA020518_002
9NDA022294ZIDOVUDINETrueAUROBINDO PHARMA LTD2009-07-23NDA022294_001
10NDA200732ZIDOVUDINETrueMATRIX LABORATORIES LTD2011-02-23NDA200732_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076844_001RXZIDOVUDINE (300MG)ORALTABLETFalseAB2005-09-19ZIDOVUDINE
2ANDA077267_001RXZIDOVUDINE (300MG)ORALTABLETFalseAB2005-09-19ZIDOVUDINE
3ANDA077327_001discontinuedZIDOVUDINE (300MG)ORALTABLETFalse2005-09-19ZIDOVUDINE
4ANDA078922_001RXZIDOVUDINE (300MG)ORALTABLETFalseAB2008-02-14ZIDOVUDINE
5ANDA090092_001RXZIDOVUDINE (300MG)ORALTABLETTrueAB2008-04-25ZIDOVUDINE
6ANDA090561_001RXZIDOVUDINE (300MG)ORALTABLETFalseAB2010-10-27ZIDOVUDINE
7ANDA202058_001RXZIDOVUDINE (300MG)ORALTABLETFalseAB2011-10-07ZIDOVUDINE
8NDA020518_001discontinuedZIDOVUDINE (200MG)ORALTABLETFalse1995-12-19RETROVIR
9NDA020518_002discontinuedZIDOVUDINE (300MG)ORALTABLETFalse1996-10-04RETROVIR
10NDA022294_001discontinuedZIDOVUDINE (60MG)ORALTABLETFalse2009-07-23ZIDOVUDINE
11NDA200732_001discontinuedZIDOVUDINE (100MG)ORALTABLETFalse2011-02-23ZIDOVUDINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11b34c6ec-ac27-455e-976e-d22cf9d81950 (view SPL)These highlights do not include all the information needed to use ZIDOVUDINE . See full prescribing information for ZIDOVUDINE. Initial U.S. Approval: 1987prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-261216950369
227370999-074b-4674-8655-e998419ec9d7 (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine tablets, USP. Zidovudine Tablets, USP Initial U.S. Approval: 1987prescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2012-10-122636294144
329489c0e-e981-4bc0-beaf-05c9a9c55c1f (view SPL)These highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine. Zidovudine tablets USP, 300mgInitial U.S. Approval: 1987prescriptionHuman PrescriptionCipla Ltd.Manufacture2012-11-235531040101
42c3264a4-1194-46a0-9343-927da4eda5b8 (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine tablets, USP.Zidovudine Tablets, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-151493490867
5425faad5-8dbc-455b-a8c3-60bdf0e2ce54 (view SPL)These highlights do not include all the information needed to use ZIDOVUDINE safely and effectively. See full prescribing information for ZIDOVUDINE.ZIDOVUDINE Tablets USP, film coated for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionLannett Company, Inc.2014-03-2529005271905
64825f6b6-b50d-4708-acaf-26ab529b6757 (view SPL)These highlights do not include all the information needed to use ZIDOVUDINE safely and effectively. See full prescribing information for ZIDOVUDINE.ZIDOVUDINE Tablets USP, film coated for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2015-05-261617860305
748b0c80a-33fd-431b-90ef-314a3834eae1 (view SPL)Zidovudine Tablets, USPThese highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine.Zidovudine (Zidovudine) TABLET for ORAL use.Initial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2015-09-171493490838
84ccc8192-fc3a-4671-a7ce-5565a7b5aaef (view SPL)These highlights do not include all the information needed to use zidovudine tablets safely and effectively. See full prescribing information for zidovudine tablets. Zidovudine Tablets, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-10-011538080878
94ce97d53-e852-49ad-92e3-24031a115e26 (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine tablets, USP. Zidovudine Tablets, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-02-102680840462
105ac42750-b856-4f4f-bc05-2758c3035250 (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine tablets, USP.Zidovudine Tablets, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-151493490867
115e0105d7-dc06-4797-b65b-d3ea5b33d2e7 (view SPL)These highlights do not include all the information needed to use ZIDOVUDINE safely and effectively. See full prescribing information for ZIDOVUDINE.ZIDOVUDINE Tablets USP, film coated for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2015-05-191617860305
1286dccc6d-83f3-4934-8ffa-b2e92ea08f86 (view SPL)Zidovudine Tablets, USPThese highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine.Zidovudine (Zidovudine) TABLET for ORAL use.Initial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-091493490838
138f13c494-6430-4e89-97d2-1becf12644c0 (view SPL)Zidovudine Tablets, USPThese highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine.Zidovudine (Zidovudine) TABLET for ORAL use.Initial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2015-10-191493490838
149a2c643d-5c5f-4427-804d-8b0eb9797157 (view SPL)These highlights do not include all the information needed to use ZIDOVUDINE . See full prescribing information for ZIDOVUDINE. Initial U.S. Approval 1987prescriptionHuman Prescription with HighlightsState Of Florida Doh Central Pharmacyrepack2010-04-131538080812
15b3d75ea7-66d5-44e9-9251-0e5967e8501b (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine tablets, USP.Zidovudine Tablets, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-151493490867
16bd5691b9-76fc-4322-a49d-18c96bc0182d (view SPL)These highlights do not include all the information needed to use ZIDOVUDINE safely and effectively. See full prescribing information for ZIDOVUDINE.ZIDOVUDINE Tablets USP, film coated for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2015-06-171617860305
17c2dbe442-bd0c-40bf-be76-b18595676dc2 (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine tablets, USP. Zidovudine Tablets, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionLucid Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-06-291523430045
18ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4 (view SPL)Zidovudine Tablets, USPThese highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine. Zidovudine (Zidovudine) TABLET for ORAL use.Initial U.S. Approval: 1987prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.MANUFACTURE2011-08-111317220509
19cd3f2a72-3f01-49ba-9efe-9f2e6fedbd01 (view SPL)These highlights do not include all the information needed to use ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for ZIDOVUDINE TABLETS. ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-10-137003786106
20d41fdad8-c67a-4fc8-a775-5b5c41c0b0e7 (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine tablets, USP.Zidovudine Tablets, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-151493490867
21d851ebb0-2370-4363-925c-628ba7fbc221 (view SPL)These highlights do not include all the information needed to use Zidovudine Tablets USP safely and effectively. See full prescribing information for Zidovudine Tablets USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-11-227000540052
22e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4 (view SPL)These highlights do not include all the information needed to use ZIDOVUDINE TABLETSsafely and effectively. See full prescribing information for ZIDOVUDINE TABLETS. ZIDOVUDINE tablets, for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-0913658620024

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