FDA.reportPublic FDA data

Application 075795

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDEGLIPIZIDETABLET;ORAL5MGNoNo
002GLIPIZIDEGLIPIZIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7968GlipizideGlipizideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7968GlipizideGlipizideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7969GlipizideGlipizideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7969GlipizideGlipizideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6637GlipizideGlipizideMajor PharmaceuticalsANDACurrent
0904-6637GlipizideGlipizideMajor PharmaceuticalsANDACurrent
10544-220GlipizideGlipizideBlenheim Pharmacal, Inc.ANDACurrent
10544-221GlipizideGlipizideBlenheim Pharmacal, Inc.ANDACurrent
33261-397GlipizideGlipizideAidarex Pharmaceuticals LLCANDACurrent
33261-433GlipizideGlipizideAidarex Pharmaceuticals LLCANDACurrent
42291-429GlipizideGlipizideAvKARE, IncANDACurrent
42291-429GlipizideGlipizideAvKAREANDACurrent
42291-430GlipizideGlipizideAvKARE, IncANDACurrent
42291-430GlipizideGlipizideAvKAREANDACurrent
42708-109GlipizideGlipizideQPharma IncANDACurrent
42708-109GlipizideGlipizideQPharma IncANDACurrent
42708-109GlipizideGlipizideQPharma IncANDACurrent
43063-861GlipizideGlipizidePD-Rx Pharmaceuticals, InANDACurrent
43063-861GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-861GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-861GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-861GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-861GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-861GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0502GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-0502GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-0505GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-0505GlipizideGlipizideA-S Medication SolutionsANDACurrent
50268-361GlipizideGlipizideAvPAKANDACurrent
50268-361GlipizideGlipizideAvPAKANDACurrent
50268-362GlipizideGlipizideAvPAKANDACurrent
50268-362GlipizideGlipizideAvPAKANDACurrent
50436-0141GlipizideGlipizideUnit Dose ServicesANDACurrent
51655-106GlipizideGlipizideNorthwind PharmaceuticalsANDACurrent
51655-106GlipizideGlipizideNorthwind PharmaceuticalsANDACurrent
51655-180GlipizideGlipizideNORTHWIND PHARMACEUTICALSANDACurrent
53002-2111GlipizideGlipizideRPK Pharmaceuticals, Inc.ANDACurrent
53002-2111GlipizideGlipizideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4462GlipizideGlipizideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4462GlipizideGlipizideRPK Pharmaceuticals, Inc.ANDACurrent
53217-349GlipizideGlipizideAidarex Pharmaceuticals LLCANDACurrent
53808-0400GlipizideGLIPIZIDEState of Florida DOH Central PharmacyANDACurrent
55154-7987GlipizideGlipizideCardinal HealthANDACurrent
55154-7987GlipizideGlipizideCardinal Health 107, LLCANDACurrent
55700-585GlipizideGlipizideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-585GlipizideGlipizideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-585GlipizideGlipizideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-624GlipizideGlipizideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-624GlipizideGlipizideLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0141GlipizideGlipizideClinical Solutions Wholesale, LLCANDACurrent
58118-0141GlipizideGlipizideClinical Solutions Wholesale, LLCANDACurrent
58118-0141GlipizideGlipizideClinical Solutions Wholesale, LLCANDACurrent
60505-0141GlipizideGlipizideApotex Corp.ANDACurrent
60505-0141GlipizideGlipizideApotex Corp.ANDACurrent
60505-0142GlipizideGlipizideApotex Corp.ANDACurrent
60505-0142GlipizideGlipizideApotex Corp.ANDACurrent
60687-690GlipizideGlipizideAmerican Health PackagingANDACurrent
60687-701GlipizideGlipizideAmerican Health PackagingANDACurrent
61919-287GLIPIZIDEGLIPIZIDEDIRECT RXANDACurrent
61919-287GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-287GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-287GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-287GLIPIZIDEGLIPIZIDEDIRECT RXANDACurrent
61919-287GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-287GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-287GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-722GLIPIZIDEGLIPIZIDEDIRECT RXANDACurrent
61919-722GLIPIZIDEGLIPIZIDEDIRECT RXANDACurrent
63187-993GlipizideGlipizideProficient Rx LPANDACurrent
63187-993GlipizideGlipizideProficient Rx LPANDACurrent
63187-993GlipizideGlipizideProficient Rx LPANDACurrent
63187-993GlipizideGlipizideProficient Rx LPANDACurrent
66267-099GlipizideGlipizideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-099GlipizideGlipizideNuCare Pharmaceuticals, Inc.ANDACurrent
67046-236GlipizideGlipizideContract Pharmacy Services-PAANDACurrent
68071-4223GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4223GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4223GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4232GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4232GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31020ORIG2001-06-13