FDA.reportPublic FDA data

Application 090869

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 2MG BASENoNo
002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 4MG BASENoNo
003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 6MG BASENoNo
004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 8MG BASENoNo
005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 12MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-3640RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3640RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3640RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3658RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3658RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3658RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3659RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3659RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3659RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3660RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3660RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3660RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3661RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3661RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent
0228-3661RopiniroleRopiniroleActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43243ORIG2012-06-22