FDA.reportPublic FDA data

Application 019129

Type
NDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAXZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENETABLET;ORAL50MG;75MGYesYes
003MAXZIDE-25HYDROCHLOROTHIAZIDE; TRIAMTERENETABLET;ORAL25MG;37.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0460MAXZIDEmaxzideMylan Pharmaceuticals Inc.NDACurrent
0378-0460MAXZIDEmaxzideMylan Pharmaceuticals Inc.NDACurrent
0378-0460MAXZIDEmaxzideMylan Pharmaceuticals Inc.NDACurrent
0378-0464MAXZIDE-25maxzideMylan Pharmaceuticals Inc.NDACurrent
0378-0464MAXZIDE-25maxzideMylan Pharmaceuticals Inc.NDACurrent
0378-0464MAXZIDE-25maxzideMylan Pharmaceuticals Inc.NDACurrent
0378-1352Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Pharmaceuticals Inc.NDACurrent
0378-1352Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Pharmaceuticals Inc.NDACurrent
0378-1352Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Pharmaceuticals Inc.NDACurrent
0378-1352Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Pharmaceuticals Inc.NDACurrent
0378-1355Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Pharmaceuticals Inc.NDACurrent
0378-1355Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Pharmaceuticals Inc.NDACurrent
0378-1355Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Pharmaceuticals Inc.NDACurrent
0378-1355Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Pharmaceuticals Inc.NDACurrent
10544-076Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBlenheim Pharmacal, Inc.NDACurrent
43063-424Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-424Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-424Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-424Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-424Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
51079-433Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Institutional Inc.NDACurrent
51079-433Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Institutional Inc.NDACurrent
51079-433Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMylan Institutional Inc.NDACurrent
55700-191Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCNDACurrent
63629-6404Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackNDACurrent
63629-6404Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackNDACurrent
63629-6712Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackNDACurrent
63629-6712Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackNDACurrent
63629-6712Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackNDACurrent
67544-102Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-102Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-408Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-408Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCNDACurrent
68788-9793Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePreferred PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64350SUPPL2020-08-21
64339SUPPL2020-08-21
33700SUPPL2011-03-28
1233SUPPL2011-03-24