FDA.reportPublic FDA data

Application 206122

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-863BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-863BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-863BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-863BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideDr. Reddy's Laboratories IncANDACurrent
50090-5101BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideA-S Medication SolutionsANDACurrent
50090-5101BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideA-S Medication SolutionsANDACurrent
50090-5101BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideA-S Medication SolutionsANDACurrent
50228-338Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-338Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-338Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
70518-2648BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2648BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2648BUPROPION HYDROCHLORIDE (SR)Bupropion HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50045APPL2017-10-12
45502ORIG2016-10-06