Diazepam Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-05-20)
Oldest Current Product
1987-10-13
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\DIAZEPAM
FDAOB
INJECTION\INJECTION\DIAZEPAM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\DIAZEPAM
INTRAMUSCULAR\INJECTION\DIAZEPAM
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\DIAZEPAM
INTRAMUSCULAR\INJECTION\DIAZEPAM

product(s) by strength(s)

diazepam 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091273ANDAHospira, Inc.1988-12-20DIAZEPAMINTRAMUSCULARINJECTION, SOLUTIONANDA07207909c6e0a1-85ad-4450-cb99-7a6b7b0d3aff, 41044928-dd1f-40bf-1fa6-709dff559124
2004093213ANDAHospira, Inc.1987-10-13DIAZEPAMINTRAMUSCULARINJECTION, SOLUTIONANDA0715830fb9bdfb-4d92-483e-acfe-4c9b2a84441c, 2c2339ed-d8d7-4fe3-f197-41adb8931fc1, 7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950889ANDARebel Distributors Corp1987-10-13DIAZEPAMINTRAMUSCULARINJECTION, SOLUTION004093213ANDA071583d1b5762f-307c-4c99-977d-d91d7dd22141
2525840213ANDAGeneral Injecatables & Vaccines, Inc2010-05-01DIAZEPAMINTRAMUSCULARINJECTION, SOLUTION004093213ANDA0715839a0ce899-0504-4095-85b1-d7957fe3f72c
3525840273ANDAGeneral Injecatables & Vaccines, Inc2010-06-01DIAZEPAMINTRAMUSCULARINJECTION004091273ANDA0720791e6c2f52-73ff-429b-8f1b-9b5b61ce1ac5
4545696044ANDAA-S Medication Solutions Llc1987-10-13DIAZEPAMINTRAMUSCULARINJECTION, SOLUTION004093213ANDA07158378668f7b-1700-410c-b9ab-66f6231228bb
5548680617ANDAPhysicians Total Care, Inc.2002-02-13DIAZEPAMINTRAMUSCULARINJECTION, SOLUTION004093213ANDA07158323d3765c-8f10-4bfc-9489-e1ed064ad813
6551546963ANDACardinal Health1988-12-20DIAZEPAMINTRAMUSCULARINJECTION, SOLUTION004091273ANDA072079b1e06f3a-8e4a-4d88-9893-83eacaeb31ea
7551546994ANDACardinal Health1987-10-13DIAZEPAMINTRAMUSCULARINJECTION, SOLUTION004093213ANDA071583e768033f-dfd6-4232-84fe-be4335d2cd50

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070296DIAZEPAMTrueWATSON LABORATORIES INC1986-02-12ANDA070296_001
2ANDA070311DIAZEPAMTrueHIKMA MAPLE LTD1985-12-16ANDA070311_001
3ANDA070312DIAZEPAMTrueHIKMA MAPLE LTD1985-12-16ANDA070312_001
4ANDA070313DIAZEPAMTrueHIKMA MAPLE LTD1985-12-16ANDA070313_001
5ANDA070662DIAZEPAMTrueABRAXIS PHARMACEUTICAL PRODUCTS1986-06-25ANDA070662_001
6ANDA070911DIAZEPAMTrueWATSON LABORATORIES INC1986-08-28ANDA070911_001
7ANDA070912DIAZEPAMTrueWATSON LABORATORIES INC1986-08-28ANDA070912_001
8ANDA070930DIAZEPAMTrueWATSON LABORATORIES INC1986-12-01ANDA070930_001
9ANDA071308DIAZEPAMTrueHIKMA MAPLE LTD1987-07-17ANDA071308_001
10ANDA071309DIAZEPAMTrueHIKMA MAPLE LTD1987-07-17ANDA071309_001
11ANDA071310DIAZEPAMTrueHIKMA MAPLE LTD1987-07-17ANDA071310_001
12ANDA071583DIAZEPAMHOSPIRA INC1987-10-13ANDA071583_001
13ANDA071584DIAZEPAMTrueHOSPIRA WORLDWIDE, INC1987-10-13ANDA071584_001
14ANDA071613DIAZEPAMTrueWARNER CHILCOTT DIV WARNER LAMBERT CO1987-10-22ANDA071613_001
15ANDA071614DIAZEPAMTrueWARNER CHILCOTT DIV WARNER LAMBERT CO1987-10-22ANDA071614_001
16ANDA072079DIAZEPAMHOSPIRA INC1988-12-20ANDA072079_001
17ANDA072370DIAZEPAMTrueWATSON LABORATORIES INC1993-01-29ANDA072370_001
18ANDA072371DIAZEPAMTrueMARSAM PHARMACEUTICALS LLC1993-01-29ANDA072371_001
19ANDA072397DIAZEPAMTrueWATSON LABORATORIES INC1993-01-29ANDA072397_001
20ANDA076815DIAZEPAMTruePARENTA PHARMACEUTICALS INC2004-04-15ANDA076815_001
21NDA016087VALIUMTrueHOFFMANN LA ROCHE INCNDA016087_001
22NDA019287DIZACTruePHARMACIA AND UPJOHN CO1993-06-18NDA019287_001
23NDA020124DIAZEPAMTrueUS ARMY MEDICAL RESEARCH MATERIEL COMMAND1990-12-05NDA020124_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070296_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1986-02-12DIAZEPAM
2ANDA070311_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1985-12-16DIAZEPAM
3ANDA070312_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1985-12-16DIAZEPAM
4ANDA070313_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1985-12-16DIAZEPAM
5ANDA070662_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1986-06-25DIAZEPAM
6ANDA070911_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1986-08-28DIAZEPAM
7ANDA070912_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1986-08-28DIAZEPAM
8ANDA070930_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1986-12-01DIAZEPAM
9ANDA071308_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1987-07-17DIAZEPAM
10ANDA071309_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1987-07-17DIAZEPAM
11ANDA071310_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1987-07-17DIAZEPAM
12ANDA071583_001RXDIAZEPAM (5MG/ML)INJECTIONTrueAP1987-10-13DIAZEPAM
13ANDA071584_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1987-10-13DIAZEPAM
14ANDA071613_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1987-10-22DIAZEPAM
15ANDA071614_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1987-10-22DIAZEPAM
16ANDA072079_001RXDIAZEPAM (5MG/ML)INJECTIONFalseAP1988-12-20DIAZEPAM
17ANDA072370_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1993-01-29DIAZEPAM
18ANDA072371_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1993-01-29DIAZEPAM
19ANDA072397_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1993-01-29DIAZEPAM
20ANDA076815_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse2004-04-15DIAZEPAM
21NDA016087_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalseVALIUM
22NDA019287_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1993-06-18DIZAC
23NDA020124_001discontinuedDIAZEPAM (5MG/ML)INJECTIONFalse1990-12-05DIAZEPAM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
109c6e0a1-85ad-4450-cb99-7a6b7b0d3aff (view SPL)DIAZEPAM INJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-1811004091273
20fb9bdfb-4d92-483e-acfe-4c9b2a84441c (view SPL)DIAZEPAM Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-05-201004093213
31e6c2f52-73ff-429b-8f1b-9b5b61ce1ac5 (view SPL)prescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-262525840273
423d3765c-8f10-4bfc-9489-e1ed064ad813 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-04-031548680617
52c2339ed-d8d7-4fe3-f197-41adb8931fc1 (view SPL)DIAZEPAM Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-1812004093213
641044928-dd1f-40bf-1fa6-709dff559124 (view SPL)DIAZEPAMINJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-185004091273
778668f7b-1700-410c-b9ab-66f6231228bb (view SPL)DIAZEPAMprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-05-021545696044
87e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f (view SPL)DIAZEPAM Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-1812004093213
99a0ce899-0504-4095-85b1-d7957fe3f72c (view SPL)Diazepam 5mg/ml 10mlprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-02-073525840213
10b1e06f3a-8e4a-4d88-9893-83eacaeb31ea (view SPL)DIAZEPAM INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-12-107551546963
11d1b5762f-307c-4c99-977d-d91d7dd22141 (view SPL)DIAZEPAM Injection, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-201216950889
12e768033f-dfd6-4232-84fe-be4335d2cd50 (view SPL)DIAZEPAM Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-04-233551546994

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