Guanfacine Oral Tablet

Brand(s)
Tenex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Reddy Pharmaceuticals, Llc (2013-05-08)
Oldest Current Product
1986-10-27
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\GUANFACINE
FDAOB
ORAL\TABLET\GUANFACINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\GUANFACINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\GUANFACINE

product(s) by strength(s)

guanfacine 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1678570705TenexNDAReddy Pharmaceuticals, Llc1986-10-27GUANFACINE HYDROCHLORIDEORALTABLETNDA019032886e050c-dd22-4f35-ac3b-243f091125c3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781160ANDAMylan Pharmaceuticals Inc.1997-01-28GUANFACINE HYDROCHLORIDEORALTABLETANDA0747966fdcebac-0a5a-4858-b0e6-87f77ba53bf1
2005910444ANDAWatson Laboratories, Inc.1995-10-17GUANFACINE HYDROCHLORIDEORALTABLETANDA074145a81b956b-f004-4426-ba20-375ccf21eb71
3428060048ANDAEpic Pharma, Llc2013-12-02GUANFACINE HYDROCHLORIDEORALTABLETANDA074673fac4a4c2-f5f0-46ef-b76b-315abe9136fa
4651620711ANDAAmneal Pharmaceuticals1998-11-25GUANFACINE HYDROCHLORIDEORALTABLETANDA075109d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046183ANDAMajor1998-11-25GUANFACINE HYDROCHLORIDEORALTABLET651620711ANDA075109d2d9e4a0-6c8a-45fa-82e7-297721a98545
2422910310ANDAAvkare, Inc.1998-11-25GUANFACINE HYDROCHLORIDEORALTABLET651620711ANDA0751097332ea0c-a7ff-cca0-4c47-39c721b47edd
3548686447ANDAPhysicians Total Care, Inc.1995-10-17GUANFACINE HYDROCHLORIDEORALTABLET005910444ANDA074145c6e30fc7-5ad3-41c1-a673-b4db53f2b98f
4551542661ANDACardinal Health1995-10-17GUANFACINE HYDROCHLORIDEORALTABLET005910444ANDA074145d5c505ea-4886-49c8-a965-3ccc43868cc6
5551546218ANDACardinal Health1997-01-27GUANFACINE HYDROCHLORIDEORALTABLET003781160ANDA074796e889f164-a92c-412d-960a-59391e4151fe
6604290124ANDAGolden State Medical Supply, Inc.2014-04-22GUANFACINE HYDROCHLORIDEORALTABLET428060048ANDA07467386ae4a58-beb1-4b4c-86ea-e65238766c1f
7647250711ANDATya Pharmaceuticals1998-11-25GUANFACINE HYDROCHLORIDEORALTABLET651620711ANDA075109a2759644-4e9d-4ad3-8dcd-f2a42b036332
8680840748ANDAAmerican Health Packaging2014-05-30GUANFACINE HYDROCHLORIDEORALTABLET651620711ANDA075109aaa95a2a-4118-4beb-953e-c4d888c91b5f
9681510623ANDACarilion Materials Management1995-10-17GUANFACINE HYDROCHLORIDEORALTABLET005910444ANDA074145adf51bff-fa50-4c72-b69e-a869a6a825fa

guanfacine 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1678570706TenexNDAReddy Pharmaceuticals, Llc1986-10-27GUANFACINE HYDROCHLORIDEORALTABLETNDA019032886e050c-dd22-4f35-ac3b-243f091125c3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781190ANDAMylan Pharmaceuticals Inc.1997-01-28GUANFACINE HYDROCHLORIDEORALTABLETANDA0747966fdcebac-0a5a-4858-b0e6-87f77ba53bf1
2005910453ANDAWatson Laboratories, Inc.1995-10-17GUANFACINE HYDROCHLORIDEORALTABLETANDA074145a81b956b-f004-4426-ba20-375ccf21eb71
3428060049ANDAEpic Pharma, Llc2013-12-02GUANFACINE HYDROCHLORIDEORALTABLETANDA074673fac4a4c2-f5f0-46ef-b76b-315abe9136fa
4651620713ANDAAmneal Pharmaceuticals1998-11-25GUANFACINE HYDROCHLORIDEORALTABLETANDA075109d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046184ANDAMajor1998-11-25GUANFACINE HYDROCHLORIDEORALTABLET651620713ANDA075109d2d9e4a0-6c8a-45fa-82e7-297721a98545
2422910311ANDAAvkare, Inc.1998-11-25GUANFACINE HYDROCHLORIDEORALTABLET651620713ANDA0751097332ea0c-a7ff-cca0-4c47-39c721b47edd
3548684876ANDAPhysicians Total Care, Inc.2003-07-31GUANFACINE HYDROCHLORIDEORALTABLET003781190ANDA074796fbf22eeb-27f5-46aa-be39-5aef43101369
4604290125ANDAGolden State Medical Supply, Inc.2014-04-22GUANFACINE HYDROCHLORIDEORALTABLET428060049ANDA07467386ae4a58-beb1-4b4c-86ea-e65238766c1f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074145GUANFACINE HYDROCHLORIDEWATSON LABORATORIES INC1995-10-17ANDA074145_001, ANDA074145_002
2ANDA074673GUANFACINE HYDROCHLORIDEEPIC PHARMA LLC1997-02-28ANDA074673_001, ANDA074673_002
3ANDA074762GUANFACINE HYDROCHLORIDETrueWATSON LABORATORIES INC1997-06-25ANDA074762_001, ANDA074762_002
4ANDA074796GUANFACINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1997-01-27ANDA074796_001, ANDA074796_002
5ANDA075109GUANFACINE HYDROCHLORIDEAMNEAL PHARMACEUTICAL1998-11-25ANDA075109_001, ANDA075109_002
6NDA019032TENEXPROMIUS PHARMA LLC1986-10-27NDA019032_001, NDA019032_002, NDA019032_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074145_001RXGUANFACINE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB1995-10-17GUANFACINE HYDROCHLORIDE
2ANDA074145_002RXGUANFACINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB1995-10-17GUANFACINE HYDROCHLORIDE
3ANDA074673_001RXGUANFACINE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB1997-02-28GUANFACINE HYDROCHLORIDE
4ANDA074673_002RXGUANFACINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB1997-02-28GUANFACINE HYDROCHLORIDE
5ANDA074762_001discontinuedGUANFACINE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalse1997-06-25GUANFACINE HYDROCHLORIDE
6ANDA074762_002discontinuedGUANFACINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalse1997-06-25GUANFACINE HYDROCHLORIDE
7ANDA074796_001RXGUANFACINE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB1997-01-27GUANFACINE HYDROCHLORIDE
8ANDA074796_002RXGUANFACINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB1997-01-27GUANFACINE HYDROCHLORIDE
9ANDA075109_001RXGUANFACINE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB1998-11-25GUANFACINE HYDROCHLORIDE
10ANDA075109_002RXGUANFACINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalseAB1998-11-25GUANFACINE HYDROCHLORIDE
11NDA019032_001RXGUANFACINE HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB1986-10-27TENEX
12NDA019032_002RXGUANFACINE HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETTrueAB1988-11-07TENEX
13NDA019032_003discontinuedGUANFACINE HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalse1988-11-07TENEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16fdcebac-0a5a-4858-b0e6-87f77ba53bf1 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-01-217003781160, 003781190
27332ea0c-a7ff-cca0-4c47-39c721b47edd (view SPL)Guanfacine Tablets, USPprescriptionHuman PrescriptionAvkare, Inc.2015-08-056422910310, 422910311
386ae4a58-beb1-4b4c-86ea-e65238766c1f (view SPL)Guanfacine Tablets USP, 1 mg and 2 mg Rx OnlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-03-232604290124, 604290125
4886e050c-dd22-4f35-ac3b-243f091125c3 (view SPL)prescriptionHuman PrescriptionReddy Pharmaceuticals, Llcmanufacture2013-05-087678570705, 678570706
5a2759644-4e9d-4ad3-8dcd-f2a42b036332 (view SPL)Guanfacine Tablets, USPprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2010-12-142647250711
6a81b956b-f004-4426-ba20-375ccf21eb71 (view SPL)Guanfacine Tablets USP Revised: April 2014 Rx only 2000647-01prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-04-0112005910444, 005910453
7aaa95a2a-4118-4beb-953e-c4d888c91b5f (view SPL)Guanfacine Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-06-121680840748
8adf51bff-fa50-4c72-b69e-a869a6a825fa (view SPL)Guanfacine Tablets USP Revised:May 2011 Rx Only 198950prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-01-302681510623
9c6e30fc7-5ad3-41c1-a673-b4db53f2b98f (view SPL)Guanfacine Tablets USP Revised: April 2014 Rx only 2000647-01prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2015-04-153548686447
10d2d9e4a0-6c8a-45fa-82e7-297721a98545 (view SPL)Guanfacine Tablets, USPprescriptionHuman PrescriptionMajor2011-02-211009046183, 009046184
11d5c505ea-4886-49c8-a965-3ccc43868cc6 (view SPL)Guanfacine Tablets USPRevised: November 2008Rx Only174350prescriptionHuman PrescriptionCardinal HealthREPACK2013-06-202551542661
12d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e (view SPL)Guanfacine Tablets, USPprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2013-08-126651620711, 651620713
13e889f164-a92c-412d-960a-59391e4151fe (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2013-03-143551546218
14fac4a4c2-f5f0-46ef-b76b-315abe9136fa (view SPL)Guanfacine Tablets USP, 1 mg and 2 mgRx OnlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-02-253428060048, 428060049
15fbf22eeb-27f5-46aa-be39-5aef43101369 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-10-251548684876

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