FDA.reportPublic FDA data

Application 076447

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo
004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo
009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0425Good Sense Aller EaseFexofenadine HClL. Perrigo CompanyANDACurrent
0113-0425Good Sense Aller EaseFexofenadine HClL. Perrigo CompanyANDACurrent
0113-0425Good Sense Aller EaseFexofenadine HClL. Perrigo CompanyANDACurrent
0113-0425Good Sense Aller EaseFexofenadine HClL. Perrigo CompanyANDACurrent
0113-0571good sense aller easefexofenadine hydrochlorideL. Perrigo CompanyANDACurrent
0113-0571good sense aller easefexofenadine hydrochlorideL. Perrigo CompanyANDACurrent
0113-0571good sense aller easefexofenadine hydrochlorideL. Perrigo CompanyANDACurrent
0113-7425basic care allergyFexofenadine HClL. Perrigo CompanyANDACurrent
0113-7425basic care allergyFexofenadine HClL. Perrigo CompanyANDACurrent
0113-7425basic care allergyFexofenadine HClL. Perrigo CompanyANDACurrent
0113-7425basic care allergyFexofenadine HClL. Perrigo CompanyANDACurrent
0113-7571basic care allergyfexofenadine hclL. Perrigo CompanyANDACurrent
0113-7571basic care allergyfexofenadine hclL. Perrigo CompanyANDACurrent
0363-0425Wal fex AllergyFexofenadine HClWalgreen CompanyANDACurrent
0363-0425Wal fex AllergyFexofenadine HClWalgreen CompanyANDACurrent
0363-0571wal fex allergyfexofenadine hydrochlorideWalgreen CompanyANDACurrent
0363-0600Wal Fex 24 Hour Allergyfexofenadine hclWalgreen CompanyANDACurrent
0363-0600Wal Fex 24 Hour Allergyfexofenadine hclWalgreen CompanyANDACurrent
0363-0600Wal Fex 24 Hour Allergyfexofenadine hclWalgreen CompanyANDACurrent
0363-0903Wal FexFexofenadine HClWalgreen CompanyANDACurrent
0363-0903Wal FexFexofenadine HClWalgreen CompanyANDACurrent
0363-0903Wal FexFexofenadine HClWalgreen CompanyANDACurrent
0536-1066rugby fexofenadine hydrochloridefexofenadine hclRugby LaboratoriesANDACurrent
0536-1066rugby fexofenadine hydrochloridefexofenadine hclRugby LaboratoriesANDACurrent
0615-7636Fexofenadine HydrochlorideFexofenadine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7695Fexofenodine HydrochlorideFexofenadineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7696Fexofenadine HydrochlorideFexofenadineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6214fexofenadine hydrochloridefexofenadine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6214fexofenadine hydrochloridefexofenadine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6979Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
0904-6979Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
0904-6979Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
0904-6979Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
0904-6979Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
10202-5717 Select Allergy Relieffexofenadine hcl7-ElevenANDACurrent
10202-5717 Select Allergy Relieffexofenadine hcl7-ElevenANDACurrent
10544-231Fexofenadine HydrochlorideFexofenadine HClBlenheim Pharmacal, Inc.ANDACurrent
11673-571up and up allergy relieffexofenadine hydrochlorideTarget CorporationANDACurrent
11673-571up and up allergy relieffexofenadine hydrochlorideTarget CorporationANDACurrent
11673-571up and up allergy relieffexofenadine hydrochlorideTarget CorporationANDACurrent
11673-571up and up allergy relieffexofenadine hydrochlorideTarget CorporationANDACurrent
11673-571up and up allergy relieffexofenadine hydrochlorideTarget CorporationANDACurrent
11673-800up and up allergy reliefFexofenadine HydrochlorideTarget CorporationANDACurrent
11673-800up and up allergy reliefFexofenadine HydrochlorideTarget CorporationANDACurrent
11822-0425allergy relieffexofenadine hydrochlorideRite Aid CorporationANDACurrent
11822-0425allergy relieffexofenadine hydrochlorideRite Aid CorporationANDACurrent
11822-0571allergy relieffexofenadine hydrochlorideRite Aid CorporationANDACurrent
11822-0571allergy relieffexofenadine hydrochlorideRite Aid CorporationANDACurrent
11822-0571allergy relieffexofenadine hydrochlorideRite Aid CorporationANDACurrent
21130-109signature care allergy relieffexofenadine hclSafewayANDACurrent
30142-061Allergy Relieffexofenadine hclKroger CompanyANDACurrent
30142-061Allergy Relieffexofenadine hclKroger CompanyANDACurrent
30142-555Allergy ReliefFexofenadine HClKroger CompanyANDACurrent
30142-555Allergy ReliefFexofenadine HClKroger CompanyANDACurrent
30142-555Allergy ReliefFexofenadine HClKroger CompanyANDACurrent
30142-555Allergy ReliefFexofenadine HClKroger CompanyANDACurrent
33261-228fexofenadine hydrochloridefexofenadine hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
35356-749fexofenadine hydrochloridefexofenadine hydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
36800-107topcare allergy reliefFexofenadine HydrochlorideTopco Associates LLCANDACurrent
36800-319topcare allergy relieffexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-319topcare allergy relieffexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-319topcare allergy relieffexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-319topcare allergy relieffexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-425Topcare fexofenadine hydrochlorideFexofenadine HClTopco Associates LLCANDACurrent
36800-425Topcare fexofenadine hydrochlorideFexofenadine HClTopco Associates LLCANDACurrent
36800-425Topcare fexofenadine hydrochlorideFexofenadine HClTopco Associates LLCANDACurrent
36800-571topcare fexofenadine hydrochloridefexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-571topcare fexofenadine hydrochloridefexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-571topcare fexofenadine hydrochloridefexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-954topcare allergy relieffexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-954topcare allergy relieffexofenadine hydrochlorideTopco Associates LLCANDACurrent
36800-954topcare allergy relieffexofenadine hydrochlorideTopco Associates LLCANDACurrent
37012-571Allergy Relieffexofenadine hclShopko Stores Operating Co., LLCANDACurrent
37012-571Allergy Relieffexofenadine hclShopko Stores Operating Co., LLCANDACurrent
37205-650leader aller easefexofenadine hydrochlorideCardinal HealthANDACurrent
37808-425Allergy ReliefFexofenadine HClH E BANDACurrent
37808-425Allergy ReliefFexofenadine HClH E BANDACurrent
37808-425Allergy ReliefFexofenadine HClH E BANDACurrent
37808-571Allergy Relieffexofenadine hydrochlorideH E BANDACurrent
37808-571Allergy Relieffexofenadine hydrochlorideH E BANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8913SUPPL2008-01-09
22558ORIG2007-07-06