Isradipine Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2014-06-01)
Oldest Current Product
2004-01-05
License(s)
ANDA
RxNORM
ORAL CAPSULE\ISRADIPINE
FDAOB
ORAL\CAPSULE\ISRADIPINE
SPL Active
ORAL\CAPSULE\ISRADIPINE
SPL Moiety
ORAL\CAPSULE\ISRADIPINE

product(s) by strength(s)

isradipine 2.5 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1162520539ANDAActavis Pharma, Inc.2004-01-05ISRADIPINEORALCAPSULEANDA077317bf3425e0-428d-4bdb-ac9a-3b9d483df83a
2428060263ANDAEpic Pharma, Llc2014-05-15ISRADIPINEORALCAPSULEANDA077169cd688799-036a-4429-88d7-da84d9762d4d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680454ANDAAvpak2014-01-06ISRADIPINEORALCAPSULE162520539ANDA077317ac51d3e3-ed76-e033-e1d6-1ffbd14d94c2
2604290385ANDAGolden State Medical Supply, Inc.2015-05-06ISRADIPINEORALCAPSULE428060263ANDA0771698194f099-d8dc-43fe-864c-e081dd201468

isradipine 5 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1162520540ANDAActavis Pharma, Inc.2006-01-05ISRADIPINEORALCAPSULEANDA077317bf3425e0-428d-4bdb-ac9a-3b9d483df83a
2428060264ANDAEpic Pharma, Llc2014-05-15ISRADIPINEORALCAPSULEANDA077169cd688799-036a-4429-88d7-da84d9762d4d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680455ANDAAvpak2014-01-06ISRADIPINEORALCAPSULE162520540ANDA077317ac51d3e3-ed76-e033-e1d6-1ffbd14d94c2
2604290386ANDAGolden State Medical Supply, Inc.2015-05-06ISRADIPINEORALCAPSULE428060264ANDA0771698194f099-d8dc-43fe-864c-e081dd201468
3681511333ANDACarilion Materials Management2006-01-05ISRADIPINEORALCAPSULE162520540ANDA077317e2f2b9a9-169f-4ccf-8974-58f21592c5bc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077169ISRADIPINEELITE LABORATORIES INC2006-04-24ANDA077169_001, ANDA077169_002
2ANDA077317ISRADIPINEWATSON LABORATORIES INC2006-01-05ANDA077317_001, ANDA077317_002
3NDA019546DYNACIRCTrueSMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE1990-12-20NDA019546_001, NDA019546_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077169_001RXISRADIPINE (2.5MG)ORALCAPSULEFalseAB2006-04-24ISRADIPINE
2ANDA077169_002RXISRADIPINE (5MG)ORALCAPSULEFalseAB2006-04-24ISRADIPINE
3ANDA077317_001RXISRADIPINE (2.5MG)ORALCAPSULEFalseAB2006-01-05ISRADIPINE
4ANDA077317_002RXISRADIPINE (5MG)ORALCAPSULETrueAB2006-01-05ISRADIPINE
5NDA019546_001discontinuedISRADIPINE (2.5MG)ORALCAPSULEFalse1990-12-20DYNACIRC
6NDA019546_002discontinuedISRADIPINE (5MG)ORALCAPSULEFalse1990-12-20DYNACIRC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18194f099-d8dc-43fe-864c-e081dd201468 (view SPL)Isradipine Capsules, USP2.5 mg and 5 mg Rx OnlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-07-231604290385, 604290386
2ac51d3e3-ed76-e033-e1d6-1ffbd14d94c2 (view SPL)Isradipine Capsules, USPprescriptionHuman PrescriptionAvpak2014-09-242502680454, 502680455
3bf3425e0-428d-4bdb-ac9a-3b9d483df83a (view SPL)Isradipine Capsules, USPprescriptionHuman PrescriptionActavis Pharma, Inc.LABEL, MANUFACTURE, PACK2014-06-014162520539, 162520540
4cd688799-036a-4429-88d7-da84d9762d4d (view SPL)Isradipine Capsules, USP2.5 mg and 5 mg Rx OnlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-02-244428060263, 428060264
5e2f2b9a9-169f-4ccf-8974-58f21592c5bc (view SPL)Isradipine Capsules, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-03-093681511333

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