Flurazepam Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-01-21)
Oldest Current Product
1985-11-27
License(s)
ANDA
RxNORM
ORAL CAPSULE\FLURAZEPAM
FDAOB
ORAL\CAPSULE\FLURAZEPAM HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\FLURAZEPAM HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\FLURAZEPAM

product(s) by strength(s)

flurazepam hydrochloride 15 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784415ANDAMylan Pharmaceuticals Inc.1985-11-27FLURAZEPAM HYDROCHLORIDEORALCAPSULEANDA0703452f2db2f5-49d3-4d47-a08a-628df49d2120

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001433367ANDAWest-Ward Pharmaceutical Corp1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULEANDA0000003839ca57-1c3d-4fb3-a00a-6569b2b4447f
2545692376ANDAA-S Medication Solutions Llc1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433367ANDA0000007c6142aa-e844-4694-a425-df0cf4b6cbd4
3604290542ANDAGolden State Medical Supply, Inc.1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433367ANDA000000d528d12f-ce31-401b-8406-7d649050198a
4636293034ANDABryant Ranch Prepack1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433367ANDA000000576e0a98-996d-425a-be7c-6ab1528539a9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680092ANDAPhysicians Total Care, Inc.1995-05-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE003784415ANDA070345347eb1a3-1957-4a4b-a0d5-1576adae3d13

flurazepam hydrochloride 30 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784430ANDAMylan Pharmaceuticals Inc.1985-11-27FLURAZEPAM HYDROCHLORIDEORALCAPSULEANDA0703452f2db2f5-49d3-4d47-a08a-628df49d2120

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001433370ANDAWest-Ward Pharmaceutical Corp1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULEANDA0711083839ca57-1c3d-4fb3-a00a-6569b2b4447f
2216950363ANDARebel Distributors Corp1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433370ANDA07110816a5de2d-2f89-4fc2-a1cf-2d6fd11f2748
3529590236ANDAH.J. Harkins Company, Inc.1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433370ANDA07110850453bda-bf59-4f1e-bf36-bc3f039b2857
4545690898ANDAA-S Medication Solutions Llc1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433370ANDA0711087c6142aa-e844-4694-a425-df0cf4b6cbd4
5604290543ANDAGolden State Medical Supply, Inc.1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433370ANDA071108d528d12f-ce31-401b-8406-7d649050198a
6636293200ANDABryant Ranch Prepack1986-12-08FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433370ANDA0711080d4472b3-0672-dab9-b0a6-97f795099140
7687880408ANDAPreferred Pharmaceuticals, Inc.2012-01-27FLURAZEPAM HYDROCHLORIDEORALCAPSULE001433370ANDA071108d3d33307-05c1-4573-9804-93087189ae80

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680093ANDAPhysicians Total Care, Inc.2002-07-152012-06-30FLURAZEPAM HYDROCHLORIDEORALCAPSULE003784430ANDA070345347eb1a3-1957-4a4b-a0d5-1576adae3d13
2552890038ANDAPd-Rx Pharmaceuticals, Inc.2010-07-16FLURAZEPAM HYDROCHLORIDEORALCAPSULE003784430ANDA070345048f5b08-71ff-4b14-bafa-922ce27a6213

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070345FLURAZEPAM HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1985-11-27ANDA070345_001, ANDA070345_002
2ANDA070444FLURAZEPAM HYDROCHLORIDETruePAR PHARMACEUTICAL INC1986-03-20ANDA070444_001
3ANDA070445FLURAZEPAM HYDROCHLORIDETruePAR PHARMACEUTICAL INC1986-03-20ANDA070445_001
4ANDA070454FLURAZEPAM HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INC1986-08-04ANDA070454_001
5ANDA070455FLURAZEPAM HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INC1986-08-04ANDA070455_001
6ANDA070562FLURAZEPAM HYDROCHLORIDETrueUSL PHARMA INC1987-07-09ANDA070562_001
7ANDA070563FLURAZEPAM HYDROCHLORIDETrueUSL PHARMA INC1987-07-09ANDA070563_001
8ANDA071068FLURAZEPAM HYDROCHLORIDETrueWATSON LABORATORIES INC1986-11-25ANDA071068_001
9ANDA071107FLURAZEPAM HYDROCHLORIDETrueHIKMA PHARMACEUTICALS LLC1986-12-08ANDA071107_001
10ANDA071108FLURAZEPAM HYDROCHLORIDETrueHIKMA PHARMACEUTICALS LLC1986-12-08ANDA071108_001
11ANDA071205FLURAZEPAM HYDROCHLORIDETrueWATSON LABORATORIES INC1986-11-25ANDA071205_001
12ANDA071551FLURAZEPAM HYDROCHLORIDETruePUREPAC PHARMACEUTICAL CO1987-09-09ANDA071551_001
13ANDA071659FLURAZEPAM HYDROCHLORIDETrueSUPERPHARM CORP1988-08-04ANDA071659_001
14ANDA071660FLURAZEPAM HYDROCHLORIDETrueSUPERPHARM CORP1988-08-04ANDA071660_001
15ANDA071716FLURAZEPAM HYDROCHLORIDETrueSANDOZ INC1991-07-31ANDA071716_001
16ANDA071717FLURAZEPAM HYDROCHLORIDETrueSANDOZ INC1991-07-31ANDA071717_001
17ANDA071767FLURAZEPAM HYDROCHLORIDETrueWARNER CHILCOTT INC1987-12-04ANDA071767_001
18ANDA071768FLURAZEPAM HYDROCHLORIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1987-12-04ANDA071768_001
19ANDA071808FLURAZEPAM HYDROCHLORIDETrueHALSEY DRUG CO INC1988-01-07ANDA071808_001
20ANDA071809FLURAZEPAM HYDROCHLORIDETrueHALSEY DRUG CO INC1988-01-07ANDA071809_001
21ANDA071927FLURAZEPAM HYDROCHLORIDETruePUREPAC PHARMACEUTICAL CO1987-09-09ANDA071927_001
22ANDA072368FLURAZEPAM HYDROCHLORIDETrueWATSON LABORATORIES INC1989-03-30ANDA072368_001
23ANDA072369FLURAZEPAM HYDROCHLORIDETrueWATSON LABORATORIES INC1989-03-30ANDA072369_001
24NDA016721DALMANETrueVALEANT PHARMACEUTICALS INTERNATIONALNDA016721_001, NDA016721_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070345_001RXFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULETrue1985-11-27FLURAZEPAM HYDROCHLORIDE
2ANDA070345_002RXFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1985-11-27FLURAZEPAM HYDROCHLORIDE
3ANDA070444_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1986-03-20FLURAZEPAM HYDROCHLORIDE
4ANDA070445_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1986-03-20FLURAZEPAM HYDROCHLORIDE
5ANDA070454_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1986-08-04FLURAZEPAM HYDROCHLORIDE
6ANDA070455_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1986-08-04FLURAZEPAM HYDROCHLORIDE
7ANDA070562_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1987-07-09FLURAZEPAM HYDROCHLORIDE
8ANDA070563_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1987-07-09FLURAZEPAM HYDROCHLORIDE
9ANDA071068_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1986-11-25FLURAZEPAM HYDROCHLORIDE
10ANDA071107_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1986-12-08FLURAZEPAM HYDROCHLORIDE
11ANDA071108_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1986-12-08FLURAZEPAM HYDROCHLORIDE
12ANDA071205_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1986-11-25FLURAZEPAM HYDROCHLORIDE
13ANDA071551_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1987-09-09FLURAZEPAM HYDROCHLORIDE
14ANDA071659_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1988-08-04FLURAZEPAM HYDROCHLORIDE
15ANDA071660_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1988-08-04FLURAZEPAM HYDROCHLORIDE
16ANDA071716_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1991-07-31FLURAZEPAM HYDROCHLORIDE
17ANDA071717_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1991-07-31FLURAZEPAM HYDROCHLORIDE
18ANDA071767_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1987-12-04FLURAZEPAM HYDROCHLORIDE
19ANDA071768_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1987-12-04FLURAZEPAM HYDROCHLORIDE
20ANDA071808_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1988-01-07FLURAZEPAM HYDROCHLORIDE
21ANDA071809_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1988-01-07FLURAZEPAM HYDROCHLORIDE
22ANDA071927_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1987-09-09FLURAZEPAM HYDROCHLORIDE
23ANDA072368_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalse1989-03-30FLURAZEPAM HYDROCHLORIDE
24ANDA072369_001discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalse1989-03-30FLURAZEPAM HYDROCHLORIDE
25NDA016721_001discontinuedFLURAZEPAM HYDROCHLORIDE (15MG)ORALCAPSULEFalseDALMANE
26NDA016721_002discontinuedFLURAZEPAM HYDROCHLORIDE (30MG)ORALCAPSULEFalseDALMANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1048f5b08-71ff-4b14-bafa-922ce27a6213 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-062552890038
20d4472b3-0672-dab9-b0a6-97f795099140 (view SPL)Flurazepam Hydrochloride Capsules, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK1986-12-081636293200
316a5de2d-2f89-4fc2-a1cf-2d6fd11f2748 (view SPL)Flurazepam Hydrochloride Capsules, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-281216950363
42f2db2f5-49d3-4d47-a08a-628df49d2120 (view SPL)These highlights do not include all the information needed to use flurazepam hydrochloride capsules safely and effectively. See full prescribing information for flurazepam hydrochloride capsules.FLURAZEPAM hydrochloride capsules, USP for oral useInitial U.S. Approval: 1970prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-01-218003784415, 003784430
5347eb1a3-1957-4a4b-a0d5-1576adae3d13 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-06-032548680092, 548680093
63839ca57-1c3d-4fb3-a00a-6569b2b4447f (view SPL)Flurazepam Hydrochloride Capsules, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2010-12-024001433367, 001433370
750453bda-bf59-4f1e-bf36-bc3f039b2857 (view SPL)Flurazepam Hydrochloride Capsules, USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-12-062529590236
8576e0a98-996d-425a-be7c-6ab1528539a9 (view SPL)Flurazepam Hydrochloride Capsules, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231000636293034
97c6142aa-e844-4694-a425-df0cf4b6cbd4 (view SPL)Flurazepam Hydrochloride Capsules, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-05-011545690898, 545692376
10d3d33307-05c1-4573-9804-93087189ae80 (view SPL)Flurazepam Hydrochloride Capsules, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2012-01-271687880408
11d528d12f-ce31-401b-8406-7d649050198a (view SPL)Flurazepam Hydrochloride Capsules, USP CIVprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290542, 604290543

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