FDA.reportPublic FDA data

Application 201408

Type
ANDA
Sponsor
TWI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 1MG BASENoNo
002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 2MG BASENoNo
003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 3MG BASENoNo
004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24979-533GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-533GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-533GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-534GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-534GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-534GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-536GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-536GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-536GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-538GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-538GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
24979-538GuanfacineGuanfacineTWi Pharmaceuticals, Inc.ANDACurrent
50090-5991GuanfacineGuanfacineA-S Medication SolutionsANDACurrent
60429-960GuanfacineGuanfacineGolden State Medical Supply Inc.ANDACurrent
60429-960GuanfacineGuanfacineGolden State Medical Supply, Inc.ANDACurrent
60429-961GuanfacineGuanfacineGolden State Medical Supply, Inc.ANDACurrent
60429-961GuanfacineGuanfacineGolden State Medical Supply Inc.ANDACurrent
60429-962GuanfacineGuanfacineGolden State Medical Supply Inc.ANDACurrent
60429-962GuanfacineGuanfacineGolden State Medical Supply, Inc.ANDACurrent
60429-963GuanfacineGuanfacineGolden State Medical Supply Inc.ANDACurrent
60429-963GuanfacineGuanfacineGolden State Medical Supply, Inc.ANDACurrent
70518-2771GuanfacineGuanfacineREMEDYREPACK INC.ANDACurrent
70518-2771GuanfacineGuanfacineREMEDYREPACK INC.ANDACurrent
70518-2771GuanfacineGuanfacineREMEDYREPACK INC.ANDACurrent
70518-2771GuanfacineGuanfacineREMEDYREPACK INC.ANDACurrent
71205-944GuanfacineGuanfacineProficient Rx LPANDACurrent
71205-944GuanfacineGuanfacineProficient Rx LPANDACurrent
71205-945GuanfacineGuanfacineProficient Rx LPANDACurrent
71205-945GuanfacineGuanfacineProficient Rx LPANDACurrent
71205-946GuanfacineGuanfacineProficient Rx LPANDACurrent
71205-946GuanfacineGuanfacineProficient Rx LPANDACurrent
71205-947GuanfacineGuanfacineProficient Rx LPANDACurrent
71205-947GuanfacineGuanfacineProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9894ORIG2015-06-04