FDA.reportPublic FDA data

Application 075640

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDECAPSULE;ORAL12.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0810HydrochlorothiazidehydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0810HydrochlorothiazidehydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0810HydrochlorothiazidehydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0615-8036HydrochlorothiazidehydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8036HydrochlorothiazidehydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-776HydrochlorothiazidehydrochlorothiazideMylan Institutional Inc.ANDACurrent
51079-776HydrochlorothiazidehydrochlorothiazideMylan Institutional Inc.ANDACurrent
51079-776HydrochlorothiazidehydrochlorothiazideMylan Institutional Inc.ANDACurrent
55154-5686HydrochlorothiazidehydrochlorothiazideCardinal HealthANDACurrent
55154-5686HydrochlorothiazidehydrochlorothiazideCardinal HealthANDACurrent
70518-0667HydrochlorothiazidehydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0667HydrochlorothiazidehydrochlorothiazideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43013ORIG2005-07-22
8748ORIG2000-01-28