hydroxyurea Oral Capsule

Brand(s)
Droxia, Hydrea
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-07-16)
Oldest Current Product
1998-10-19
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\HYDROXYUREA
FDAOB
ORAL\CAPSULE\HYDROXYUREA
SPL Active
ORAL\CAPSULE\HYDROXYUREA
SPL Moiety
ORAL\CAPSULE\HYDROXYUREA

product(s) by strength(s)

hydroxyurea 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000036335DroxiaNDAE.R. Squibb & Sons, L.L.C.2009-06-01HYDROXYUREAORALCAPSULENDA016295740e054b-faac-7c27-f06d-a56efb699355

hydroxyurea 300 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000036336DroxiaNDAE.R. Squibb & Sons, L.L.C.2009-06-01HYDROXYUREAORALCAPSULENDA016295740e054b-faac-7c27-f06d-a56efb699355

hydroxyurea 400 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000036337DroxiaNDAE.R. Squibb & Sons, L.L.C.2009-06-01HYDROXYUREAORALCAPSULENDA016295740e054b-faac-7c27-f06d-a56efb699355

hydroxyurea 500 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000030830HydreaNDAE.R. Squibb & Sons, L.L.C.2009-06-01HYDROXYUREAORALCAPSULENDA016295050bd2a2-a125-721a-e366-255c5466f018

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550882ANDABarr Laboratories Inc.1998-10-19HYDROXYUREAORALCAPSULEANDA075143b9514ae5-79ae-4cc2-9d7f-c8f7806d1694
2498840724ANDAPar Pharmaceutical Companies, Inc.1999-02-24HYDROXYUREAORALCAPSULEANDA0753409e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910321ANDAAvkare, Inc.2013-07-19HYDROXYUREAORALCAPSULE005550882ANDA075143862583ff-6d5c-3f7d-e3bd-352fb0400928
2548684773ANDAPhysicians Total Care, Inc.2003-04-11HYDROXYUREAORALCAPSULE005550882ANDA0751437a2e2305-78bd-4077-96c6-59c5059201ab
3604290265ANDAGolden State Medical Supply, Inc.1999-02-24HYDROXYUREAORALCAPSULE498840724ANDA0753400a5c7030-5fac-4708-b309-f9d07103285a
4680840284ANDAAmerican Health Packaging2008-08-12HYDROXYUREAORALCAPSULE498840724ANDA075340c84a2241-6c05-480f-8a5b-049e08c27d73

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074476HYDROXYUREATrueROXANE LABORATORIES INC1995-08-18ANDA074476_001
2ANDA075020HYDROXYUREATrueBARR LABORATORIES INC1998-07-30ANDA075020_001, ANDA075020_002
3ANDA075143HYDROXYUREABARR LABORATORIES INC1998-10-16ANDA075143_001, ANDA075143_002
4ANDA075340HYDROXYUREAPAR PHARMACEUTICAL INC1999-02-24ANDA075340_001
5NDA016295DROXIABRISTOL MYERS SQUIBB CONDA016295_001, NDA016295_002, NDA016295_003, NDA016295_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074476_001discontinuedHYDROXYUREA (500MG)ORALCAPSULEFalse1995-08-18HYDROXYUREA
2ANDA075020_001discontinuedHYDROXYUREA (500MG)ORALCAPSULEFalse1998-07-30HYDROXYUREA
3ANDA075020_002discontinuedHYDROXYUREA (250MG)ORALCAPSULEFalse2000-06-26HYDROXYUREA
4ANDA075143_001RXHYDROXYUREA (500MG)ORALCAPSULEFalseAB1998-10-16HYDROXYUREA
5ANDA075143_002discontinuedHYDROXYUREA (250MG)ORALCAPSULEFalse2000-09-21HYDROXYUREA
6ANDA075340_001RXHYDROXYUREA (500MG)ORALCAPSULEFalseAB1999-02-24HYDROXYUREA
7NDA016295_001RXHYDROXYUREA (500MG)ORALCAPSULETrueABDROXIA
8NDA016295_002RXHYDROXYUREA (200MG)ORALCAPSULEFalse1998-02-25DROXIA
9NDA016295_003RXHYDROXYUREA (300MG)ORALCAPSULEFalse1998-02-25DROXIA
10NDA016295_004RXHYDROXYUREA (400MG)ORALCAPSULEFalse1998-02-25DROXIA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1050bd2a2-a125-721a-e366-255c5466f018 (view SPL)These highlights do not include all the information needed to use HYDREA safely and effectively. See full prescribing information for HYDREA. HYDREA (hydroxyurea) capsules, for oral useInitial U.S. Approval: 1967prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-07-167000030830
20a5c7030-5fac-4708-b309-f9d07103285a (view SPL)HYDROXYUREA 500mg capsuleprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-10-151604290265
3740e054b-faac-7c27-f06d-a56efb699355 (view SPL)These highlights do not include all the information needed to use DROXIA safely and effectively. See full prescribing information for DROXIA.DROXIA (hydroxyurea) capsules, for oral useInitial U.S. Approval: 1967prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-07-167000036335, 000036336, 000036337
47a2e2305-78bd-4077-96c6-59c5059201ab (view SPL)HYDROXYUREA CAPSULES USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-012548684773
5862583ff-6d5c-3f7d-e3bd-352fb0400928 (view SPL)HYDROXYUREA CAPSULES USPprescriptionHuman PrescriptionAvkare, Inc.2013-07-193422910321
69e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.manufacture2012-02-167498840724
7b9514ae5-79ae-4cc2-9d7f-c8f7806d1694 (view SPL)These highlights do not include all the information needed to use hydroxyurea capsules USP safely and effectively. See full prescribing information for hydroxyurea capsules USP.HYDROXYUREA capsules, for oral useInitial U.S. Approval: 1967prescriptionHuman PrescriptionBarr Laboratories Inc.2015-08-278005550882
8c84a2241-6c05-480f-8a5b-049e08c27d73 (view SPL)HYDROXYUREA CAPSULES, USP Rx OnlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-153680840284

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