Diazepam Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2012-07-30)
Oldest Current Product
1987-04-03
License(s)
ANDA
RxNORM
ORAL SOLUTION\DIAZEPAM
FDAOB
ORAL\CONCENTRATE\DIAZEPAM
ORAL\SOLUTION\DIAZEPAM
SPL Active
ORAL\SOLUTION, CONCENTRATE\DIAZEPAM
ORAL\SOLUTION\DIAZEPAM
SPL Moiety
ORAL\SOLUTION, CONCENTRATE\DIAZEPAM
ORAL\SOLUTION\DIAZEPAM

product(s) by strength(s)

diazepam 1 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543188ANDARoxane Laboratories, Inc1987-04-03DIAZEPAMORALSOLUTIONANDA0709281aaf9375-ae3d-4fed-9cd1-24102e00be1a
2000548207ANDARoxane Laboratories, Inc1990-06-14DIAZEPAMORALSOLUTIONANDA0709281aaf9375-ae3d-4fed-9cd1-24102e00be1a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178563188ANDAAtlantic Biologicals Corps1987-04-03DIAZEPAMORALSOLUTION000543188ANDA0709285051e98b-3817-61aa-dba8-bd8be2f0c086
2551541584ANDACardinal Health2012-02-22DIAZEPAMORALSOLUTION680940750ANDA0709284c18233e-d667-4d6b-9e38-8d37518e4b0e
3680940750ANDAPrecision Dose Inc.2012-02-22DIAZEPAMORALSOLUTION000543188ANDA07092878d5a77d-5ca7-4f16-b4d0-fce86456593c

diazepam 5 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543185ANDARoxane Laboratories, Inc1987-04-03DIAZEPAMORALSOLUTION, CONCENTRATEANDA0714151aaf9375-ae3d-4fed-9cd1-24102e00be1a
2005271768ANDALannett Company, Inc.2014-04-14DIAZEPAMORALSOLUTION, CONCENTRATEANDA204433b8cb8fe7-3744-41fa-8981-05a7fa8a2ec3

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA070928DIAZEPAMROXANE LABORATORIES INC1987-04-03ANDA070928_001
2ANDA071415DIAZEPAM INTENSOLROXANE LABORATORIES INC1987-04-03ANDA071415_001
3ANDA204433DIAZEPAMLANNETT HOLDINGS INC2014-04-14ANDA204433_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070928_001RXDIAZEPAM (5MG/5ML)ORALSOLUTIONTrue1987-04-03DIAZEPAM
2ANDA071415_001RXDIAZEPAM (5MG/ML)ORALCONCENTRATETrueAA1987-04-03DIAZEPAM INTENSOL
3ANDA204433_001RXDIAZEPAM (5MG/ML)ORALCONCENTRATEFalseAA2014-04-14DIAZEPAM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11aaf9375-ae3d-4fed-9cd1-24102e00be1a (view SPL)DIAZEPAM ORAL SOLUTION, CIV, 5 mg per 5 mL and DIAZEPAM INTENSOL Oral Solution (Concentrate), CIV, 5 mg per mLprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-07-303000543185, 000543188, 000548207
24c18233e-d667-4d6b-9e38-8d37518e4b0e (view SPL)DIAZEPAM Oral Solution 5 mg per 5 mL CIVprescriptionHuman PrescriptionCardinal HealthREPACK2014-05-221551541584
35051e98b-3817-61aa-dba8-bd8be2f0c086 (view SPL)DIAZEPAM ORAL SOLUTION, CIVprescriptionHuman PrescriptionAtlantic Biologicals CorpsREPACK1987-04-031178563188
478d5a77d-5ca7-4f16-b4d0-fce86456593c (view SPL)DIAZEPAM Oral Solution 5 mg per 5 mL CIVprescriptionHuman PrescriptionPrecision Dose Inc.2012-02-231680940750
5b8cb8fe7-3744-41fa-8981-05a7fa8a2ec3 (view SPL)Diazepam Oral Solution (Concentrate) CIVRX ONLYprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-04-1617005271768

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