Zidovudine Oral Capsule

Brand(s)
Retrovir
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-02-05)
Oldest Current Product
2006-03-27
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\ZIDOVUDINE
FDAOB
ORAL\CAPSULE\ZIDOVUDINE
SPL Active
ORAL\CAPSULE\ZIDOVUDINE
SPL Moiety
ORAL\CAPSULE\ZIDOVUDINE

product(s) by strength(s)

zidovudine 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020211RetrovirNDAViiv Healthcare Company2010-10-28ZIDOVUDINEORALCAPSULENDA0196556df09f15-b102-431c-adde-d7aeef6f5d84

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1427990403ANDAEdenbridge Pharmaceuticals, Llc2012-04-01ZIDOVUDINEORALCAPSULEANDA078349a3c2532a-5880-4d52-b2a1-2e6d4dbd6021
2523430044ANDALucid Pharma Llc2006-03-27ZIDOVUDINEORALCAPSULEANDA07812854e21b7b-939c-4afa-9492-bde2b36dd352
3531040100ANDACipla Ltd.2007-05-23ZIDOVUDINEORALCAPSULEANDA078349536735fc-566c-4ad4-b83e-602199ff82b4
4643760128ANDABoca Pharmacal, Llc2012-08-17ZIDOVUDINEORALCAPSULEANDA0783499681028f-9b57-4266-b1c5-4b04205d2df4
5658620107ANDAAurobindo Pharma Limited2006-03-27ZIDOVUDINEORALCAPSULEANDA0781289907acb2-e4a0-46f9-93c0-a8d7b7ce98cf

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680840461ANDAAmerican Health Packaging2013-07-05ZIDOVUDINEORALCAPSULE658620107ANDA078128c08ed05f-89ff-4620-8bc6-60419fa02131

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078128ZIDOVUDINEAUROBINDO PHARMA LTD INC2006-03-27ANDA078128_001
2ANDA078349ZIDOVUDINECIPLA LTD2007-05-23ANDA078349_001
3NDA019655RETROVIRVIIV HEALTHCARE CO1987-03-19NDA019655_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078128_001RXZIDOVUDINE (100MG)ORALCAPSULEFalseAB2006-03-27ZIDOVUDINE
2ANDA078349_001RXZIDOVUDINE (100MG)ORALCAPSULEFalseAB2007-05-23ZIDOVUDINE
3NDA019655_001RXZIDOVUDINE (100MG)ORALCAPSULETrueAB1987-03-19RETROVIR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1536735fc-566c-4ad4-b83e-602199ff82b4 (view SPL)These highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine. Zidovudine capsules USP , 100 mg , for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionCipla Ltd.2015-07-307531040100
254e21b7b-939c-4afa-9492-bde2b36dd352 (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine capsules, USP.Zidovudine Capsules, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionLucid Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-06-291523430044
36df09f15-b102-431c-adde-d7aeef6f5d84 (view SPL)These highlights do not include all the information needed to use RETROVIR safely and effectively. See full prescribing information for RETROVIR.RETROVIR (zidovudine) capsules, for oral useRETROVIR (zidovudine) syrup, for oral useRETROVIR (zidovudine) injection, for intravenous useInitial U.S. Approval: 1987prescriptionHuman PrescriptionViiv Healthcare Company2015-02-0512497020211, 497020212, 497020213Zidovudine Injectable Solution
Zidovudine Oral Solution
49681028f-9b57-4266-b1c5-4b04205d2df4 (view SPL)These highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine. Zidovudine (Zidovudine) CAPSULE for ORAL use.Initial U.S. Approval: 1987prescriptionHuman PrescriptionBoca Pharmacal, Llc2013-09-302643760128
59907acb2-e4a0-46f9-93c0-a8d7b7ce98cf (view SPL)These highlights do not include all the information needed to use zidovudine capsules, USPsafely and effectively. See full prescribing information for zidovudine capsules, USP. ZIDOVUDINE capsules, USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-02-109658620107
6a3c2532a-5880-4d52-b2a1-2e6d4dbd6021 (view SPL)These highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine. Initial U.S. Approval: 1987prescriptionHuman PrescriptionEdenbridge Pharmaceuticals, LlcMANUFACTURE2012-04-011427990403
7c08ed05f-89ff-4620-8bc6-60419fa02131 (view SPL)These highlights do not include all the information needed to use zidovudine safely and effectively. See full prescribing information for zidovudine capsules, USP.Zidovudine Capsules, USPInitial U.S. Approval: 1987prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-04-303680840461

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