Clonidine Injectable Solution

Brand(s)
Duraclon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Llc (2012-06-29)
Oldest Current Product
1996-10-02
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\CLONIDINE
FDAOB
INJECTION\INJECTION\CLONIDINE HYDROCHLORIDE\rdfq
SPL Active
EPIDURAL\INJECTION, SOLUTION\CLONIDINE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\CLONIDINE HYDROCHLORIDE
SPL Moiety
EPIDURAL\INJECTION, SOLUTION\CLONIDINE
INTRAVENOUS\INJECTION, SOLUTION\CLONIDINE

product(s) by strength(s)

clonidine hydrochloride 0.1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570218DuraclonNDAMylan Institutional Llc1996-10-02CLONIDINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONNDA0206158c126bb8-732a-4949-8754-2f50b5543638

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439724ANDAWest-Ward Pharmaceutical Corp2011-01-01CLONIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA2003002a5b46ec-4c16-48a5-9e58-8d28a3f21274
2005170730ANDAAmerican Regent, Inc.2010-04-15CLONIDINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA091104f6798f73-b5a6-434b-a627-aa102b123dd5
3398222000ANDAX-Gen Pharmaceuticals, Inc.2013-10-29CLONIDINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA203167ada02f1f-ae78-4435-879e-492ae862d504
4633230405ANDAApp Pharmaceuticals, Llc2011-07-08CLONIDINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA200673c60f781a-ad68-419a-8f87-137664f2bb43

clonidine hydrochloride 0.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570219DuraclonNDAMylan Institutional Llc1996-10-02CLONIDINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONNDA0206158c126bb8-732a-4949-8754-2f50b5543638

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439723ANDAWest-Ward Pharmaceutical Corp2011-01-01CLONIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA2003002a5b46ec-4c16-48a5-9e58-8d28a3f21274
2005170731ANDAAmerican Regent, Inc.2010-04-15CLONIDINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA091104f6798f73-b5a6-434b-a627-aa102b123dd5
3398222010ANDAX-Gen Pharmaceuticals, Inc.2013-10-29CLONIDINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA203167ada02f1f-ae78-4435-879e-492ae862d504
4633230427ANDAApp Pharmaceuticals, Llc2011-07-08CLONIDINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA200673c60f781a-ad68-419a-8f87-137664f2bb43

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA091104CLONIDINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC2009-10-08ANDA091104_001, ANDA091104_002
2ANDA200300CLONIDINE HYDROCHLORIDEHIKMA FARMACEUTICA (PORTUGAL) SA2011-01-26ANDA200300_001, ANDA200300_002
3ANDA200673CLONIDINE HYDROCHLORIDEFRESENIUS KABI USA LLC2011-07-08ANDA200673_001, ANDA200673_002
4ANDA202601CLONIDINE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2014-02-20ANDA202601_001, ANDA202601_002
5ANDA203167CLONIDINE HYDROCHLORIDEEXELA PHARMA SCIENCES LLC2013-10-29ANDA203167_001, ANDA203167_002
6NDA020615DURACLONMYLAN INSTITUTIONAL LLC1996-10-02NDA020615_001, NDA020615_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA091104_001RXCLONIDINE HYDROCHLORIDE (1MG/10ML)INJECTIONFalseAP2009-10-08CLONIDINE HYDROCHLORIDE
2ANDA091104_002RXCLONIDINE HYDROCHLORIDE (5MG/10ML)INJECTIONFalseAP2009-10-08CLONIDINE HYDROCHLORIDE
3ANDA200300_001RXCLONIDINE HYDROCHLORIDE (1MG/10ML)INJECTIONFalseAP2011-01-26CLONIDINE HYDROCHLORIDE
4ANDA200300_002RXCLONIDINE HYDROCHLORIDE (5MG/10ML)INJECTIONFalseAP2011-01-26CLONIDINE HYDROCHLORIDE
5ANDA200673_001RXCLONIDINE HYDROCHLORIDE (1MG/10ML)INJECTIONFalseAP2011-07-08CLONIDINE HYDROCHLORIDE
6ANDA200673_002RXCLONIDINE HYDROCHLORIDE (5MG/10ML)INJECTIONFalseAP2011-07-08CLONIDINE HYDROCHLORIDE
7ANDA202601_001RXCLONIDINE HYDROCHLORIDE (1MG/10ML)INJECTIONFalseAP2014-02-20CLONIDINE HYDROCHLORIDE
8ANDA202601_002RXCLONIDINE HYDROCHLORIDE (5MG/10ML)INJECTIONFalseAP2014-02-20CLONIDINE HYDROCHLORIDE
9ANDA203167_001RXCLONIDINE HYDROCHLORIDE (1MG/10ML)INJECTIONFalseAP2013-10-29CLONIDINE HYDROCHLORIDE
10ANDA203167_002RXCLONIDINE HYDROCHLORIDE (5MG/10ML)INJECTIONFalseAP2013-10-29CLONIDINE HYDROCHLORIDE
11NDA020615_001RXCLONIDINE HYDROCHLORIDE (1MG/10ML)INJECTIONFalseAP1996-10-02DURACLON
12NDA020615_002RXCLONIDINE HYDROCHLORIDE (5MG/10ML)INJECTIONTrueAP1999-04-27DURACLON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12a5b46ec-4c16-48a5-9e58-8d28a3f21274 (view SPL)Clonidine HCl InjectionprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2011-06-022001439723, 001439724
28c126bb8-732a-4949-8754-2f50b5543638 (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2012-06-293674570218, 674570219
3ada02f1f-ae78-4435-879e-492ae862d504 (view SPL)Clonidine Hydrochloride InjectionprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2014-02-125398222000, 398222010
4c60f781a-ad68-419a-8f87-137664f2bb43 (view SPL)Clonidine Hydrochloride InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-09-303633230405, 633230427
5f6798f73-b5a6-434b-a627-aa102b123dd5 (view SPL)CLONIDINE HYDROCHLORIDE INJECTIONprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE2013-10-223005170730, 005170731

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