meropenem Injectable Solution

Brand(s)
Merrem
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-04-30)
Oldest Current Product
1996-09-23
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\MEROPENEM
FDAOB
INJECTION\INJECTION\MEROPENEM\rdfq
IV (INFUSION)\POWDER\MEROPENEM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\MEROPENEM
INTRAVENOUS\INJECTION, SOLUTION\MEROPENEM: SODIUM CHLORIDE
INTRAVENOUS\INJECTION\MEROPENEM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\MEROPENEM ANHYDROUS
INTRAVENOUS\INJECTION, SOLUTION\MEROPENEM ANHYDROUS: SODIUM CATION
INTRAVENOUS\INJECTION\MEROPENEM ANHYDROUS

product(s) by strength(s)

meropenem 10 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002643183NDAB. Braun Medical Inc.2015-04-30MEROPENEM, SODIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA2021063b952a55-6ef7-45c8-be21-16eefe37ec2e

meropenem 20 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002643185NDAB. Braun Medical Inc.2015-04-30MEROPENEM, SODIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA2021063b952a55-6ef7-45c8-be21-16eefe37ec2e

meropenem 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003100325MerremNDAAstrazeneca Pharmaceuticals Lp1996-09-23MEROPENEMINTRAVENOUSINJECTIONNDA050706c15e88d3-d903-4e7a-f683-e29f51afa848

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093505ANDAHospira, Inc.2010-06-23MEROPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA090940a27ce7d2-0b75-47e8-9a7e-1e561b603216
2004093506ANDAHospira, Inc.2010-06-23MEROPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA090940a27ce7d2-0b75-47e8-9a7e-1e561b603216
3007813265ANDASandoz Inc2011-03-29MEROPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA091201a0fcc561-9566-4223-84b3-baa5cf3e0a20
4007813267ANDASandoz Inc2011-03-29MEROPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA091201a0fcc561-9566-4223-84b3-baa5cf3e0a20
5633230507ANDAApp Pharmaceuticals, Llc2011-10-14MEROPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA09140412714f80-d6e5-4453-b66c-62f57c16ddfc, 185181e3-c004-4d61-b992-5df94fe57a90, 7a68d899-2678-43a9-a9c1-ef8f916b562f
6633230508ANDAApp Pharmaceuticals, Llc2011-10-26MEROPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA09140412714f80-d6e5-4453-b66c-62f57c16ddfc, 185181e3-c004-4d61-b992-5df94fe57a90, 7a68d899-2678-43a9-a9c1-ef8f916b562f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544744ANDACardinal Health2010-06-23MEROPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION004093505ANDA090940b79a4b53-0b1b-4f39-b58c-e7d1d0358f83
2551547825ANDACardinal Health2010-06-23MEROPENEMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION004093506ANDA090940b79a4b53-0b1b-4f39-b58c-e7d1d0358f83

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090940MEROPENEMHOSPIRA INC2010-06-22ANDA090940_001, ANDA090940_002
2ANDA091201MEROPENEMSANDOZ INC2011-03-29ANDA091201_001, ANDA091201_002
3ANDA091404MEROPENEMACS DOBFAR SPA2011-10-26ANDA091404_001, ANDA091404_002
4NDA050706MERREMASTRAZENECA UK LTD1996-06-21NDA050706_001, NDA050706_003
5NDA202106MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINERB BRAUN MEDICAL INC2015-04-30NDA202106_001, NDA202106_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA090940_001RXMEROPENEM (500MG/VIAL)INJECTIONFalseAP2010-06-22MEROPENEM
2ANDA090940_002RXMEROPENEM (1GM/VIAL)INJECTIONFalseAP2010-06-22MEROPENEM
3ANDA091201_001RXMEROPENEM (500MG/VIAL)INJECTIONFalseAP2011-03-29MEROPENEM
4ANDA091201_002RXMEROPENEM (1GM/VIAL)INJECTIONFalseAP2011-03-29MEROPENEM
5ANDA091404_001RXMEROPENEM (500MG/VIAL)INJECTIONFalseAP2011-10-26MEROPENEM
6ANDA091404_002RXMEROPENEM (1GM/VIAL)INJECTIONFalseAP2011-10-26MEROPENEM
7NDA050706_001RXMEROPENEM (1GM/VIAL)INJECTIONTrueAP1996-06-21MERREM
8NDA050706_003RXMEROPENEM (500MG/VIAL)INJECTIONTrueAP1996-06-21MERREM
9NDA202106_001RXMEROPENEM (500MG/VIAL)POWDERFalse2015-04-30MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
10NDA202106_002RXMEROPENEM (1GM/VIAL)POWDERFalse2015-04-30MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112714f80-d6e5-4453-b66c-62f57c16ddfc (view SPL)These highlights do not include all the information needed to use Meropenem for injection (I.V.) safely and effectively. See full prescribing information for Meropenem for injection (I.V.). MEROPENEM FOR INJECTION, USP (I.V.)Initial U.S. Approval: 1996prescriptionHuman PrescriptionApp Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2015-10-085633230507, 633230508
2185181e3-c004-4d61-b992-5df94fe57a90 (view SPL)These highlights do not include all the information needed to use Meropenem for injection (I.V.) safely and effectively. See full prescribing information for Meropenem for injection (I.V.). MEROPENEM FOR INJECTION, USP (I.V.)Initial U.S. Approval: 1996prescriptionHuman PrescriptionApp Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2015-10-048633230507, 633230508
33b952a55-6ef7-45c8-be21-16eefe37ec2e (view SPL)These highlights do not include all the information needed to use MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP. MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP IN DUPLEX CONTAINER, for intravenous use Initial U.S. Approval: 1996prescriptionHuman PrescriptionB. Braun Medical Inc.2015-04-309002643183, 002643185
47a68d899-2678-43a9-a9c1-ef8f916b562f (view SPL)These highlights do not include all the information needed to use Meropenem for injection (I.V.) safely and effectively. See full prescribing information for Meropenem for injection (I.V.). MEROPENEM FOR INJECTION, USP (I.V.)Initial U.S. Approval: 1996prescriptionHuman PrescriptionApp Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2015-10-042633230507, 633230508
5a0fcc561-9566-4223-84b3-baa5cf3e0a20 (view SPL)These highlights do not include all the information needed to use Meropenem for Injection safely and effectively. See full prescribing information for Meropenem for Injection. Meropenem for InjectionInitial U.S. Approval: 1996To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionSandoz Inc2013-04-0217007813265, 007813267
6a27ce7d2-0b75-47e8-9a7e-1e561b603216 (view SPL)These highlights do not include all the information needed to use MEROPENEM FOR INJECTION I.V. safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION I.V. MEROPENEM FOR INJECTION, USP (I.V.)Initial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2015-05-089004093505, 004093506
7b79a4b53-0b1b-4f39-b58c-e7d1d0358f83 (view SPL)These highlights do not include all the information needed to use Meropenem for Injection I.V. safely and effectively. See full prescribing information for Meropenem for Injection I.V. Meropenem for Injection, USP (I.V.) Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection I.V. and other antibacterial drugs, Meropenem for Injection I.V. should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionCardinal HealthREPACK2015-05-212551544744, 551547825
8c15e88d3-d903-4e7a-f683-e29f51afa848 (view SPL)These highlights do not include all the information needed to use MERREM I.V. safely and effectively. See full prescribing information for MERREM I.V. MERREM I.V. (meropenem for Injection)Initial U.S. Approval: 1996prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-04-3014003100325, 003100321

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