Application 076269

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7267Metformin HydrochlorideMetformin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7267Metformin HydrochlorideMetformin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-5583Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42708-075Metformin HydrochlorideMetformin HydrochlorideQPharma IncANDACurrent
66116-433Metformin HydrochlorideMetformin HydrochlorideMedVantx, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8884ORIG2004-06-21