FDA.reportPublic FDA data

Application 079148

Type
ANDA
Sponsor
INDICUS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL850MGNoNo
003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7626Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7627Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7628Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-253Metformin hydrochlorideMetformin hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-255Metformin hydrochlorideMetformin hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
24724-014Metformin hydrochlorideMetformin hydrochlorideINDICUS PHARMA LLCANDACurrent
24724-014Metformin hydrochlorideMetformin hydrochlorideINDICUS PHARMA LLCANDACurrent
24724-015Metformin hydrochlorideMetformin hydrochlorideINDICUS PHARMA LLCANDACurrent
24724-015Metformin hydrochlorideMetformin hydrochlorideINDICUS PHARMA LLCANDACurrent
24724-016Metformin hydrochlorideMetformin hydrochlorideINDICUS PHARMA LLCANDACurrent
24724-016Metformin hydrochlorideMetformin hydrochlorideINDICUS PHARMA LLCANDACurrent
43547-248Metformin hydrochlorideMetformin hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-249Metformin hydrochlorideMetformin hydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-250Metformin hydrochlorideMetformin hydrochlorideSolco healthcare U.S., LLCANDACurrent
63629-1396Metformin hydrochlorideMetformin hydrochlorideBryant Ranch PrepackANDACurrent
63629-1396Metformin hydrochlorideMetformin hydrochlorideBryant Ranch PrepackANDACurrent