pamidronate Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira Worldwide, Inc. (2014-07-22)
Oldest Current Product
2002-04-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\PAMIDRONATE
FDAOB
INJECTION\INJECTION\PAMIDRONATE DISODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PAMIDRONATE DISODIUM
INTRAVENOUS\INJECTION, SOLUTION\PAMIDRONATE DISODIUM
INTRAVENOUS\INJECTION\PAMIDRONATE DISODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PAMIDRONIC ACID
INTRAVENOUS\INJECTION, SOLUTION\PAMIDRONIC ACID
INTRAVENOUS\INJECTION\PAMIDRONIC ACID

product(s) by strength(s)

pamidronate disodium 3 mg/ml injectable solution

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1005170745American Regent, Inc.PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTION9337c108-2d51-4322-be3c-f3e879069f86

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690107ANDAPfizer Labs2011-05-10PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA078520a8ba3ed0-7047-400e-8037-ebc058024637
2000690186ANDAPfizer Labs2011-05-10PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA078520ebd26191-b497-4904-b158-ca3b0bcd178b
3007034075ANDATeva Parenteral Medicines, Inc2002-04-01PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA076153d3f15563-21af-4e0d-a9f1-1ebc596c848f
4250210802ANDASagent Pharmaceuticals2010-01-15PAMIDRONATE DISODIUMINTRAVENOUSINJECTIONANDA078373246ad093-0419-48a2-8d11-f2c5806156c1
5599230601ANDAAreva Pharmaceuticals,Inc.2013-08-06PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0774335db8c103-2bfd-a235-d50d-4c1a356d44d2
6617030324ANDAHospira Worldwide, Inc.2002-06-27PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA0758419b6a9a3b-71c9-4dcb-b857-5d1de25c3a23
7633230734ANDAApp Pharmaceuticals, Llc2002-05-19PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA076207ad1b83f9-ddf7-44b7-9234-77d6872e4825
8674570430ANDAMylan Institutional Llc2008-11-01PAMIDRONATE DISODIUMINTRAVENOUSINJECTIONANDA078520c2ca033e-fa5f-4141-b702-11f8b4303da1

pamidronate disodium 6 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1599230602ANDAAreva Pharmaceuticals,Inc.2013-08-06PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0774335db8c103-2bfd-a235-d50d-4c1a356d44d2
2617030325ANDAHospira Worldwide, Inc.2002-06-27PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA0758419b6a9a3b-71c9-4dcb-b857-5d1de25c3a23

pamidronate disodium 9 mg/ml injectable solution

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1005170746American Regent, Inc.PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTION9337c108-2d51-4322-be3c-f3e879069f86

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690109ANDAPfizer Labs2011-05-10PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA078520a8ba3ed0-7047-400e-8037-ebc058024637
2007034085ANDATeva Parenteral Medicines, Inc2002-04-01PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA076153d3f15563-21af-4e0d-a9f1-1ebc596c848f
3250210803ANDASagent Pharmaceuticals2010-01-15PAMIDRONATE DISODIUMINTRAVENOUSINJECTIONANDA078373246ad093-0419-48a2-8d11-f2c5806156c1
4599230603ANDAAreva Pharmaceuticals,Inc.2013-08-06PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0774335db8c103-2bfd-a235-d50d-4c1a356d44d2
5617030326ANDAHospira Worldwide, Inc.2002-06-27PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA0758419b6a9a3b-71c9-4dcb-b857-5d1de25c3a23
6633230735ANDAApp Pharmaceuticals, Llc2002-05-19PAMIDRONATE DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA076207ad1b83f9-ddf7-44b7-9234-77d6872e4825
7674570610ANDAMylan Institutional Llc2008-11-01PAMIDRONATE DISODIUMINTRAVENOUSINJECTIONANDA07852082e8deb5-2368-4267-8286-b7782acca952

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075290PAMIDRONATE DISODIUMEUROHEALTH INTERNATIONAL SARL2001-04-30ANDA075290_001, ANDA075290_003
2ANDA075594PAMIDRONATE DISODIUMTrueAESGEN INC2002-05-06ANDA075594_001, ANDA075594_002
3ANDA075773PAMIDRONATE DISODIUMFRESENIUS KABI USA LLC2002-05-06ANDA075773_001, ANDA075773_002
4ANDA075841PAMIDRONATE DISODIUMHOSPIRA INC2002-06-27ANDA075841_001, ANDA075841_002, ANDA075841_003
5ANDA076153PAMIDRONATE DISODIUMTEVA PHARMACEUTICALS USA2002-03-27ANDA076153_001, ANDA076153_002
6ANDA076207PAMIDRONATE DISODIUMFRESENIUS KABI USA LLC2002-05-17ANDA076207_001, ANDA076207_002
7ANDA077433PAMIDRONATE DISODIUMAREVA PHARMACEUTICALS INC2008-11-26ANDA077433_001, ANDA077433_002, ANDA077433_003
8ANDA077703PAMIDRONATE DISODIUMSUN PHARMA GLOBAL INC2008-12-24ANDA077703_001, ANDA077703_002
9ANDA078156PAMIDRONATE DISODIUMPLIVA LACHEMA AS2008-08-19ANDA078156_001, ANDA078156_002, ANDA078156_003
10ANDA078300PAMIDRONATE DISODIUMTrueMN PHARMACEUTICALS2009-03-10ANDA078300_001, ANDA078300_002
11ANDA078373PAMIDRONATE DISODIUMMUSTAFA NEVZAT ILAC SANAYII AS2008-12-23ANDA078373_001, ANDA078373_002
12ANDA078520PAMIDRONATE DISODIUMMYLAN LABORATORIES LTD2008-10-31ANDA078520_001, ANDA078520_002
13ANDA078942PAMIDRONATE DISODIUMLUITPOLD PHARMACEUTICALS INC2008-07-25ANDA078942_001, ANDA078942_002
14NDA020036AREDIATrueNOVARTIS PHARMACEUTICALS CORP1991-10-31NDA020036_001, NDA020036_003, NDA020036_004
15NDA021113PAMIDRONATE DISODIUMEUROHEALTH INTERNATIONAL SARL2002-03-04NDA021113_001, NDA021113_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075290_001RXPAMIDRONATE DISODIUM (30MG/VIAL)INJECTIONFalseAP2001-04-30PAMIDRONATE DISODIUM
2ANDA075290_003RXPAMIDRONATE DISODIUM (90MG/VIAL)INJECTIONFalseAP2001-04-30PAMIDRONATE DISODIUM
3ANDA075594_001discontinuedPAMIDRONATE DISODIUM (30MG/VIAL)INJECTIONFalse2002-05-06PAMIDRONATE DISODIUM
4ANDA075594_002discontinuedPAMIDRONATE DISODIUM (90MG/VIAL)INJECTIONFalse2002-05-06PAMIDRONATE DISODIUM
5ANDA075773_001RXPAMIDRONATE DISODIUM (30MG/VIAL)INJECTIONFalseAP2002-05-06PAMIDRONATE DISODIUM
6ANDA075773_002RXPAMIDRONATE DISODIUM (90MG/VIAL)INJECTIONFalseAP2002-05-06PAMIDRONATE DISODIUM
7ANDA075841_001RXPAMIDRONATE DISODIUM (30MG/10ML)INJECTIONTrueAP2002-06-27PAMIDRONATE DISODIUM
8ANDA075841_002RXPAMIDRONATE DISODIUM (60MG/10ML)INJECTIONTrueAP2002-06-27PAMIDRONATE DISODIUM
9ANDA075841_003RXPAMIDRONATE DISODIUM (90MG/10ML)INJECTIONTrueAP2002-06-27PAMIDRONATE DISODIUM
10ANDA076153_001RXPAMIDRONATE DISODIUM (30MG/10ML)INJECTIONFalseAP2002-03-27PAMIDRONATE DISODIUM
11ANDA076153_002RXPAMIDRONATE DISODIUM (90MG/10ML)INJECTIONFalseAP2002-03-27PAMIDRONATE DISODIUM
12ANDA076207_001RXPAMIDRONATE DISODIUM (30MG/10ML)INJECTIONFalseAP2002-05-17PAMIDRONATE DISODIUM
13ANDA076207_002RXPAMIDRONATE DISODIUM (90MG/10ML)INJECTIONFalseAP2002-05-17PAMIDRONATE DISODIUM
14ANDA077433_001RXPAMIDRONATE DISODIUM (30MG/VIAL)INJECTIONFalseAP2008-11-26PAMIDRONATE DISODIUM
15ANDA077433_002RXPAMIDRONATE DISODIUM (60MG/VIAL)INJECTIONFalseAP2008-11-26PAMIDRONATE DISODIUM
16ANDA077433_003RXPAMIDRONATE DISODIUM (90MG/VIAL)INJECTIONFalseAP2008-11-26PAMIDRONATE DISODIUM
17ANDA077703_001RXPAMIDRONATE DISODIUM (30MG/VIAL)INJECTIONFalseAP2008-12-24PAMIDRONATE DISODIUM
18ANDA077703_002RXPAMIDRONATE DISODIUM (90MG/VIAL)INJECTIONFalseAP2008-12-24PAMIDRONATE DISODIUM
19ANDA078156_001RXPAMIDRONATE DISODIUM (30MG/10ML)INJECTIONFalseAP2008-08-19PAMIDRONATE DISODIUM
20ANDA078156_002RXPAMIDRONATE DISODIUM (60MG/10ML)INJECTIONFalseAP2008-08-19PAMIDRONATE DISODIUM
21ANDA078156_003RXPAMIDRONATE DISODIUM (90MG/10ML)INJECTIONFalseAP2008-08-19PAMIDRONATE DISODIUM
22ANDA078300_001discontinuedPAMIDRONATE DISODIUM (30MG/VIAL)INJECTIONFalse2009-03-10PAMIDRONATE DISODIUM
23ANDA078300_002discontinuedPAMIDRONATE DISODIUM (90MG/VIAL)INJECTIONFalse2009-03-10PAMIDRONATE DISODIUM
24ANDA078373_001RXPAMIDRONATE DISODIUM (30MG/10ML)INJECTIONFalseAP2008-12-23PAMIDRONATE DISODIUM
25ANDA078373_002RXPAMIDRONATE DISODIUM (90MG/10ML)INJECTIONFalseAP2008-12-23PAMIDRONATE DISODIUM
26ANDA078520_001RXPAMIDRONATE DISODIUM (30MG/10ML)INJECTIONFalseAP2008-10-31PAMIDRONATE DISODIUM
27ANDA078520_002RXPAMIDRONATE DISODIUM (90MG/10ML)INJECTIONFalseAP2008-10-31PAMIDRONATE DISODIUM
28ANDA078942_001RXPAMIDRONATE DISODIUM (30MG/10ML)INJECTIONFalseAP2008-07-25PAMIDRONATE DISODIUM
29ANDA078942_002RXPAMIDRONATE DISODIUM (90MG/10ML)INJECTIONFalseAP2008-07-25PAMIDRONATE DISODIUM
30NDA020036_001discontinuedPAMIDRONATE DISODIUM (30MG/VIAL)INJECTIONFalse1991-10-31AREDIA
31NDA020036_003discontinuedPAMIDRONATE DISODIUM (60MG/VIAL)INJECTIONFalse1993-05-06AREDIA
32NDA020036_004discontinuedPAMIDRONATE DISODIUM (90MG/VIAL)INJECTIONFalse1993-05-06AREDIA
33NDA021113_001RXPAMIDRONATE DISODIUM (30MG/10ML)INJECTIONTrueAP2002-03-04PAMIDRONATE DISODIUM
34NDA021113_002RXPAMIDRONATE DISODIUM (90MG/10ML)INJECTIONTrueAP2002-03-04PAMIDRONATE DISODIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1246ad093-0419-48a2-8d11-f2c5806156c1 (view SPL)PAMIDRONATE DISODIUM INJECTIONprescriptionHuman PrescriptionSagent PharmaceuticalsMANUFACTURE2009-11-032250210802, 250210803
25db8c103-2bfd-a235-d50d-4c1a356d44d2 (view SPL)Pamidronate Disodium for Injection USP For Intravenous Infusion Rx onlyprescriptionHuman PrescriptionAreva Pharmaceuticals,Inc.MANUFACTURE2012-09-062599230601, 599230602, 599230603
382e8deb5-2368-4267-8286-b7782acca952 (view SPL)Pamidronate Disodium InjectionprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-10-171674570610
49337c108-2d51-4322-be3c-f3e879069f86 (view SPL)PAMIDRONATE DISODIUM INJECTIONprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE2015-03-094005170745, 005170746
59b6a9a3b-71c9-4dcb-b857-5d1de25c3a23 (view SPL)Pamidronate Disodium InjectionprescriptionHuman PrescriptionHospira Worldwide, Inc.2014-07-2213617030324, 617030325, 617030326
6a8ba3ed0-7047-400e-8037-ebc058024637 (view SPL)pamidronate disodium injectionprescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, MANUFACTURE2011-02-252000690107, 000690109
7ad1b83f9-ddf7-44b7-9234-77d6872e4825 (view SPL)Pamidronate Disodium InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-08-081633230734, 633230735
8c2ca033e-fa5f-4141-b702-11f8b4303da1 (view SPL)Pamidronate Disodium InjectionprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-01-031674570430
9d3f15563-21af-4e0d-a9f1-1ebc596c848f (view SPL)These highlights do not include all the information needed to use pamidronate disodium injection safely and effectively. See full prescribing information for pamidronate disodium injection. PAMIDRONATE DISODIUM injection, for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-02-059007034075, 007034085
10ebd26191-b497-4904-b158-ca3b0bcd178b (view SPL)Pamidronate Disodium InjectionprescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE2013-11-212000690186

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