Buprenorphine Sublingual Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2015-01-23)
Oldest Current Product
2009-10-08
License(s)
NDA, ANDA
RxNORM
SUBLINGUAL TABLET\BUPRENORPHINE
FDAOB
SUBLINGUAL\TABLET\BUPRENORPHINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\BUPRENORPHINE
ORAL\TABLET\BUPRENORPHINE HYDROCHLORIDE
SUBLINGUAL\TABLET\BUPRENORPHINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\BUPRENORPHINE
SUBLINGUAL\TABLET\BUPRENORPHINE

product(s) by strength(s)

buprenorphine 2 mg sublingual tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540176ANDARoxane Laboratories, Inc2009-10-08BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA0786331bf8b35a-b769-465c-a2f8-099868dfcd2f
2000935378ANDATeva Pharmaceuticals Usa Inc2010-05-25BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA090360c3b4fb4e-db70-407f-8481-8ae934ef73f0
3002283156ANDAActavis Elizabeth Llc2015-03-23BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA09081903819118-86f6-4329-adaf-4599e7b71f46
4003780923ANDAMylan Pharmaceuticals Inc.2015-03-06BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA2010667a85f424-9d83-49d9-8a17-478abce6fddd
5503830924ANDAHi-Tech Pharmacal Co., Inc.2010-09-24BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA090622a891f3ff-5cad-4e92-b4c4-d5108c8df550

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490421ANDARemedyrepack Inc.2010-12-07BUPRENORPHINEORALTABLET000935378ANDA090360db2b617c-2709-476d-ad4b-02ee58874494
2493490554ANDARemedyrepack Inc.2010-12-07BUPRENORPHINE HYDROCHLORIDEORALTABLET000540176ANDA078633cd1b7a2b-b0fe-4d5b-b4ae-6b3885fddfd8
3521250678ANDARemedyrepack Inc.2013-07-25BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLET503830924ANDA09062263c8f575-ae8a-45d0-b58d-b0a0582b097d
4551544962ANDACardinal Health2009-10-08BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLET000540176ANDA078633601cc950-ee0f-4a57-8e79-7b4a012b1d11

buprenorphine 8 mg sublingual tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540177ANDARoxane Laboratories, Inc2009-10-08BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA0786331bf8b35a-b769-465c-a2f8-099868dfcd2f
2000935379ANDATeva Pharmaceuticals Usa Inc2010-05-25BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA090360c3b4fb4e-db70-407f-8481-8ae934ef73f0
3002283153ANDAActavis Elizabeth Llc2015-03-23BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA09081903819118-86f6-4329-adaf-4599e7b71f46
4003780924ANDAMylan Pharmaceuticals Inc.2015-03-06BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA2010667a85f424-9d83-49d9-8a17-478abce6fddd
5503830930ANDAHi-Tech Pharmacal Co., Inc.2010-09-24BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLETANDA090622a891f3ff-5cad-4e92-b4c4-d5108c8df550

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1636294092NDABryant Ranch Prepack2009-10-09BUPRENORPHINE HYDROCHLORIDEORALTABLET124961310NDA0207327830fe02-a2ec-48cf-85ce-3e3f6dadab4e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250649ANDARemedyrepack Inc.2013-06-24BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLET503830930ANDA0906225efb3e1f-e908-4ed4-85d1-7961878d7fc5
2545696578ANDAA-S Medication Solutions Llc2010-09-24BUPRENORPHINE HYDROCHLORIDESUBLINGUALTABLET503830930ANDA090622a7abaae6-5ab4-454f-a082-34d637326dbf

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA078633BUPRENORPHINE HYDROCHLORIDEROXANE LABORATORIES INC2009-10-08ANDA078633_001, ANDA078633_002
2ANDA090279BUPRENORPHINE HYDROCHLORIDESANDOZ INC2015-06-10ANDA090279_001, ANDA090279_002
3ANDA090360BUPRENORPHINE HYDROCHLORIDEBARR LABORATORIES INC2010-05-07ANDA090360_001, ANDA090360_002
4ANDA090622BUPRENORPHINE HYDROCHLORIDEETHYPHARM2010-09-24ANDA090622_001, ANDA090622_002
5ANDA090819BUPRENORPHINE HYDROCHLORIDEACTAVIS ELIZABETH LLC2015-02-19ANDA090819_001, ANDA090819_002
6ANDA201066BUPRENORPHINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2015-03-06ANDA201066_001, ANDA201066_002
7NDA020732SUBUTEXTrueINDIVIOR INC2002-10-08NDA020732_002, NDA020732_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078633_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 2MG BASE)SUBLINGUALTABLETFalseAB2009-10-08BUPRENORPHINE HYDROCHLORIDE
2ANDA078633_002RXBUPRENORPHINE HYDROCHLORIDE (EQ 8MG BASE)SUBLINGUALTABLETTrueAB2009-10-08BUPRENORPHINE HYDROCHLORIDE
3ANDA090279_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 2MG BASE)SUBLINGUALTABLETFalseAB2015-06-10BUPRENORPHINE HYDROCHLORIDE
4ANDA090279_002RXBUPRENORPHINE HYDROCHLORIDE (EQ 8MG BASE)SUBLINGUALTABLETFalseAB2015-06-10BUPRENORPHINE HYDROCHLORIDE
5ANDA090360_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 2MG BASE)SUBLINGUALTABLETFalseAB2010-05-07BUPRENORPHINE HYDROCHLORIDE
6ANDA090360_002RXBUPRENORPHINE HYDROCHLORIDE (EQ 8MG BASE)SUBLINGUALTABLETFalseAB2010-05-07BUPRENORPHINE HYDROCHLORIDE
7ANDA090622_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 2MG BASE)SUBLINGUALTABLETFalseAB2010-09-24BUPRENORPHINE HYDROCHLORIDE
8ANDA090622_002RXBUPRENORPHINE HYDROCHLORIDE (EQ 8MG BASE)SUBLINGUALTABLETFalseAB2010-09-24BUPRENORPHINE HYDROCHLORIDE
9ANDA090819_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 2MG BASE)SUBLINGUALTABLETFalseAB2015-02-19BUPRENORPHINE HYDROCHLORIDE
10ANDA090819_002RXBUPRENORPHINE HYDROCHLORIDE (EQ 8MG BASE)SUBLINGUALTABLETFalseAB2015-02-19BUPRENORPHINE HYDROCHLORIDE
11ANDA201066_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 2MG BASE)SUBLINGUALTABLETFalseAB2015-03-06BUPRENORPHINE HYDROCHLORIDE
12ANDA201066_002RXBUPRENORPHINE HYDROCHLORIDE (EQ 8MG BASE)SUBLINGUALTABLETFalseAB2015-03-06BUPRENORPHINE HYDROCHLORIDE
13NDA020732_002discontinuedBUPRENORPHINE HYDROCHLORIDE (EQ 2MG BASE)SUBLINGUALTABLETFalse2002-10-08SUBUTEX
14NDA020732_003discontinuedBUPRENORPHINE HYDROCHLORIDE (EQ 8MG BASE)SUBLINGUALTABLETFalse2002-10-08SUBUTEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103819118-86f6-4329-adaf-4599e7b71f46 (view SPL)These highlights do not include all the information needed to use buprenorphine sublingual tablet safely and effectively. See full prescribing information for buprenorphine sublingual tablet. BUPRENORPHINE sublingual tablet for sublingual administration CIII Initial U.S. Approval: 2002prescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-01-233002283153, 002283156
21bf8b35a-b769-465c-a2f8-099868dfcd2f (view SPL)These highlights do not include all the information needed to use BUPRENORPHINE sublingual tablets safely and effectively. See full prescribing information for BUPRENORPHINE sublingual tablets.BUPRENORPHINE sublingual tablets for sublingual administration CIIIInitial U.S. Approval: 2002prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-01-238000540176, 000540177
35efb3e1f-e908-4ed4-85d1-7961878d7fc5 (view SPL)Buprenorphine Hydrochloride Sublingual Tablets, 2 mg and 8 mg (Base) (CIII)prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-241521250649
4601cc950-ee0f-4a57-8e79-7b4a012b1d11 (view SPL)BUPRENORPHINE HCl SUBLINGUAL TABLETS (CIII)prescriptionHuman PrescriptionCardinal HealthREPACK2012-01-092551544962
563c8f575-ae8a-45d0-b58d-b0a0582b097d (view SPL)Buprenorphine Hydrochloride Sublingual Tablets, 2 mg and 8 mg (Base) (CIII)prescriptionHuman PrescriptionRemedyrepack Inc.2013-07-252521250678
67830fe02-a2ec-48cf-85ce-3e3f6dadab4e (view SPL)Buprenorphine hydrochloride 8mgprescriptionHuman PrescriptionBryant Ranch Prepackrepack2009-10-091002636294092
77a85f424-9d83-49d9-8a17-478abce6fddd (view SPL)These highlights do not include all the information needed to use buprenorphine hydrochloride sublingual tablets safely and effectively. See full prescribing information for buprenorphine hydrochloride sublingual tablets. BUPRENORPHINE hydrochloride sublingual tablets for sublingual administration CIIIInitial U.S. Approval: 2002prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-12-264003780923, 003780924
8a7abaae6-5ab4-454f-a082-34d637326dbf (view SPL)These highlights do not include all the information needed to use Buprenorphine HCl Sublingual Tablets safely and effectively. See full prescribing information for Buprenorphine HCl Sublingual Tablets. Initial U.S. Approval: 2002prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2015-01-021545696578
9a891f3ff-5cad-4e92-b4c4-d5108c8df550 (view SPL)These highlights do not include all the information needed to use Buprenorphine HCl Sublingual Tablets safely and effectively. See full prescribing information for Buprenorphine HCl Sublingual Tablets. BUPRENORPHINE hydrochloride sublingual tablets for sublingual administration CIII Initial U.S. Approval: 2002prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.ANALYSIS, MANUFACTURE, PACK2015-11-1310503830924, 503830930
10c3b4fb4e-db70-407f-8481-8ae934ef73f0 (view SPL)These highlights do not include all the information needed to use Buprenorphine Sublingual Tablets safely and effectively. See full prescribing information for Buprenorphine Sublingual Tablets. BUPRENORPHINE sublingual tablets for sublingual administration CIII Initial U.S. Approval: 2002prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-015000935378, 000935379
11cd1b7a2b-b0fe-4d5b-b4ae-6b3885fddfd8 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-12-07130493490554
12db2b617c-2709-476d-ad4b-02ee58874494 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-12-07130493490421

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