FDA.reportPublic FDA data

Application 206674

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGNoNo
003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-744BUPROPION HYDROCHLORIDEBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-744BUPROPION HYDROCHLORIDEBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-744BUPROPION HYDROCHLORIDEBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-744BUPROPION HYDROCHLORIDEBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-633BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideMedsource PharmaceuticalsANDACurrent
50090-3249BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideA-S Medication SolutionsANDACurrent
50090-3453BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideA-S Medication SolutionsANDACurrent
53002-1509BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1509BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-252Bupropion HydrochlorideBupropion HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55700-487Bupropion HydrochlorideBupropion HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0878BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0878BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
69097-877BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideCipla USA Inc.,ANDACurrent
69097-878BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideCipla USA Inc.,ANDACurrent
69097-879BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideCipla USA Inc.,ANDACurrent
70518-1033BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1033BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-156BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-156BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-156BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0006BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0006BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0025BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0025BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10590ORIG2016-02-12