Atracurium Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aurobindo Pharma Limited (2015-07-29)
Oldest Current Product
2012-05-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\ATRACURIUM
FDAOB
INJECTION\INJECTION\ATRACURIUM BESYLATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ATRACURIUM BESYLATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ATRACURIUM

product(s) by strength(s)

atracurium besylate 10 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091105ANDAHospira, Inc.2012-10-18ATRACURIUM BESYLATEINTRAVENOUSINJECTION, SOLUTIONANDA090761de1c2dcd-295b-47ce-b7a1-a8be59939a54
2250210672ANDASagent Pharmaceuticals2012-05-01, 2015-07-31ATRACURIUM BESYLATEINTRAVENOUSINJECTION, SOLUTIONANDA0914895562756e-7475-2d4c-696e-757834416c6c, 98ed3c4c-5e53-46c1-8110-6ae41531e36b, f25cc5a7-0eb0-4902-b402-fe021d7051da
3551500217ANDAAuromedics Pharma Llc2015-04-08ATRACURIUM BESYLATEINTRAVENOUSINJECTION, SOLUTIONANDA206011f7b6a720-05a7-4d6a-9200-21bdc90fc1c4
4658620985ANDAAurobindo Pharma Limited2015-04-08ATRACURIUM BESYLATEINTRAVENOUSINJECTION, SOLUTIONANDA206011c3e0a3b9-535d-456b-9a1f-fa18a4d4e38f

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA074632ATRACURIUM BESYLATETrueHOSPIRA INC1996-12-23ANDA074632_001Atracurium Injection
2ANDA074633ATRACURIUM BESYLATE PRESERVATIVE FREETrueHOSPIRA INC1996-12-23ANDA074633_001Atracurium Injection
3ANDA074639ATRACURIUM BESYLATE PRESERVATIVE FREETrueHOSPIRA INC1997-03-25ANDA074639_001Atracurium Injection
4ANDA074740ATRACURIUM BESYLATETrueHOSPIRA INC1997-03-28ANDA074740_001Atracurium Injection
5ANDA074741ATRACURIUM BESYLATE PRESERVATIVE FREETrueHOSPIRA INC1997-03-28ANDA074741_001Atracurium Injection
6ANDA074753ATRACURIUM BESYLATETrueBAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE1997-01-23ANDA074753_001Atracurium Injection
7ANDA074768ATRACURIUM BESYLATE PRESERVATIVE FREETrueBAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE1997-01-23ANDA074768_001Atracurium Injection
8ANDA074784ATRACURIUM BESYLATETrueTEVA PARENTERAL MEDICINES INC1997-06-11ANDA074784_001Atracurium Injection
9ANDA074824ATRACURIUM BESYLATETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1997-09-30ANDA074824_001Atracurium Injection
10ANDA074825ATRACURIUM BESYLATE PRESERVATIVE FREETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1997-09-30ANDA074825_001Atracurium Injection
11ANDA074900ATRACURIUM BESYLATE PRESERVATIVE FREEEUROHEALTH INTERNATIONAL SARL1997-07-18ANDA074900_001Atracurium Injection
12ANDA074901ATRACURIUM BESYLATEEUROHEALTH INTERNATIONAL SARL1997-07-18ANDA074901_001Atracurium Injection
13ANDA074944ATRACURIUM BESYLATE PRESERVATIVE FREETrueWATSON LABORATORIES INC1998-07-28ANDA074944_001Atracurium Injection
14ANDA074945ATRACURIUM BESYLATETrueWATSON LABORATORIES INC1998-07-28ANDA074945_001Atracurium Injection
15ANDA090761ATRACURIUM BESYLATEHOSPIRA INC2012-10-18ANDA090761_001Atracurium Injection
16ANDA090782ATRACURIUM BESYLATE PRESERVATIVE FREEHOSPIRA INC2012-10-18ANDA090782_001Atracurium Injection
17ANDA091488ATRACURIUM BESYLATE PRESERVATIVE FREESAGENT PHARMACEUTICALS INC2012-02-17ANDA091488_001Atracurium Injection
18ANDA091489ATRACURIUM BESYLATESAGENT PHARMACEUTICALS INC2012-02-17ANDA091489_001Atracurium Injection
19ANDA206010ATRACURIUM BESYLATE PRESERVATIVE FREEAUROBINDO PHARMA LTD2015-04-08ANDA206010_001Atracurium Injection
20ANDA206011ATRACURIUM BESYLATEAUROBINDO PHARMA LTD2015-04-08ANDA206011_001Atracurium Injection
21NDA018831TRACRIUMTrueHOSPIRA INC1983-11-23NDA018831_001, NDA018831_002Atracurium Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074632_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1996-12-23ATRACURIUM BESYLATE
2ANDA074633_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1996-12-23ATRACURIUM BESYLATE PRESERVATIVE FREE
3ANDA074639_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1997-03-25ATRACURIUM BESYLATE PRESERVATIVE FREE
4ANDA074740_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1997-03-28ATRACURIUM BESYLATE
5ANDA074741_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1997-03-28ATRACURIUM BESYLATE PRESERVATIVE FREE
6ANDA074753_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1997-01-23ATRACURIUM BESYLATE
7ANDA074768_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1997-01-23ATRACURIUM BESYLATE PRESERVATIVE FREE
8ANDA074784_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1997-06-11ATRACURIUM BESYLATE
9ANDA074824_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1997-09-30ATRACURIUM BESYLATE
10ANDA074825_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1997-09-30ATRACURIUM BESYLATE PRESERVATIVE FREE
11ANDA074900_001RXATRACURIUM BESYLATE (10MG/ML)INJECTIONTrueAP1997-07-18ATRACURIUM BESYLATE PRESERVATIVE FREE
12ANDA074901_001RXATRACURIUM BESYLATE (10MG/ML)INJECTIONTrueAP1997-07-18ATRACURIUM BESYLATE
13ANDA074944_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1998-07-28ATRACURIUM BESYLATE PRESERVATIVE FREE
14ANDA074945_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1998-07-28ATRACURIUM BESYLATE
15ANDA090761_001RXATRACURIUM BESYLATE (10MG/ML)INJECTIONFalseAP2012-10-18ATRACURIUM BESYLATE
16ANDA090782_001RXATRACURIUM BESYLATE (10MG/ML)INJECTIONFalseAP2012-10-18ATRACURIUM BESYLATE PRESERVATIVE FREE
17ANDA091488_001RXATRACURIUM BESYLATE (10MG/ML)INJECTIONFalseAP2012-02-17ATRACURIUM BESYLATE PRESERVATIVE FREE
18ANDA091489_001RXATRACURIUM BESYLATE (10MG/ML)INJECTIONFalseAP2012-02-17ATRACURIUM BESYLATE
19ANDA206010_001RXATRACURIUM BESYLATE (10MG/ML)INJECTIONFalseAP2015-04-08ATRACURIUM BESYLATE PRESERVATIVE FREE
20ANDA206011_001RXATRACURIUM BESYLATE (10MG/ML)INJECTIONFalseAP2015-04-08ATRACURIUM BESYLATE
21NDA018831_001discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1983-11-23TRACRIUM
22NDA018831_002discontinuedATRACURIUM BESYLATE (10MG/ML)INJECTIONFalse1985-06-20TRACRIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
15562756e-7475-2d4c-696e-757834416c6c (view SPL)Atracurium Besylate Injection, USP(For Intravenous Injection)prescriptionHuman PrescriptionSagent Pharmaceuticals2014-12-227250210672, 250210659Atracurium Injection
298ed3c4c-5e53-46c1-8110-6ae41531e36b (view SPL)Atracurium Besylate Injection, USP(For Intravenous Injection)prescriptionHuman PrescriptionSagent Pharmaceuticals2015-07-092250210672, 250210659Atracurium Injection
3c3e0a3b9-535d-456b-9a1f-fa18a4d4e38f (view SPL)prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, MANUFACTURE2015-07-291658620985
4de1c2dcd-295b-47ce-b7a1-a8be59939a54 (view SPL)ATRACURIUM BESYLATE INJECTION USPprescriptionHuman PrescriptionHospira, Inc.2012-10-221004091105, 004091109Atracurium Injection
5f25cc5a7-0eb0-4902-b402-fe021d7051da (view SPL)Atracurium Besylate Injection, USP(For Intravenous Injection)prescriptionHuman PrescriptionSagent Pharmaceuticals2015-07-095250210672, 250210659Atracurium Injection
6f7b6a720-05a7-4d6a-9200-21bdc90fc1c4 (view SPL)prescriptionHuman PrescriptionAuromedics Pharma Llc2015-04-301551500217

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