Application 012546

Type
NDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENUATE DOSPANDIETHYLPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL75MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0782Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochlorideActavis Pharma, Inc.NDACurrent
12634-691diethylpropion hydrochloride erdiethylpropion hydrochloride erApotheca Inc.NDACurrent
50090-0121Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochlorideA-S Medication SolutionsNDACurrent
63629-2967Diethylpropion HClDiethylpropion hydrochlorideBryant Ranch PrepackNDACurrent
66267-077Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochlorideNuCare Pharmaceuticals, Inc.NDACurrent
66267-077Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochlorideNuCare Pharmaceuticals, Inc.NDACurrent
68788-0686Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochloridePreferred Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12020SUPPL2004-09-07
10814SUPPL2004-09-07