FDA.reportPublic FDA data

Application 075580

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATETABLET;ORALEQ 1MG BASENoNo
002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATETABLET;ORALEQ 2MG BASENoNo
003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATETABLET;ORALEQ 4MG BASENoNo
004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATETABLET;ORALEQ 8MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5522DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5522DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5522DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5522DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5523DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5523DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5523DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5523DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5524DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5524DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5524DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
0904-5524DoxazosinDoxazosinMajor PharmaceuticalsANDACurrent
42291-258DoxazosinDoxazosinAvKARE, Inc.ANDACurrent
42291-258DoxazosinDoxazosinAvKAREANDACurrent
42291-258DoxazosinDoxazosinAvKAREANDACurrent
42291-259DoxazosinDoxazosinAvKARE, Inc.ANDACurrent
42291-259DoxazosinDoxazosinAvKAREANDACurrent
42291-259DoxazosinDoxazosinAvKAREANDACurrent
42291-260DoxazosinDoxazosinAvKARE, Inc.ANDACurrent
42291-260DoxazosinDoxazosinAvKAREANDACurrent
42291-260DoxazosinDoxazosinAvKAREANDACurrent
43063-739DoxazosinDoxazosinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-739DoxazosinDoxazosinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-739DoxazosinDoxazosinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-739DoxazosinDoxazosinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-739DoxazosinDoxazosinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-739DoxazosinDoxazosinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0701DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0701DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0701DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0704DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0704DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0704DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0706DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0706DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0734DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0734DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-0734DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50090-2434DoxazosinDoxazosinA-S Medication SolutionsANDACurrent
50268-222DoxazosinDoxazosinAvPAKANDACurrent
50268-223DoxazosinDoxazosinAvPAKANDACurrent
50268-224DoxazosinDoxazosinAvPAKANDACurrent
50268-225DoxazosinDoxazosinAvPAKANDACurrent
53808-0364DoxazosinDOXAZOSIN MESYLATEState of Florida DOH Central PharmacyANDACurrent
55154-7996DoxazosinDoxazosinCardinal Health 107, LLCANDACurrent
55154-7996DoxazosinDoxazosinCardinal HealthANDACurrent
60505-0093DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0093DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0093DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0094DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0094DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0094DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0095DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0095DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0095DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0096DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0096DoxazosinDoxazosinApotex Corp.ANDACurrent
60505-0096DoxazosinDoxazosinApotex Corp.ANDACurrent
68071-3298DoxazosinDoxazosinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3298DoxazosinDoxazosinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3341DoxazosinDoxazosinNuCare Pharmaceuticals, Inc.ANDACurrent
68084-836DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-836DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-836DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-836DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-851DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-851DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-851DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-851DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-862DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-862DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-862DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68084-862DoxazosinDoxazosinAmerican Health PackagingANDACurrent
68645-463DoxazosinDoxazosinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-463DoxazosinDoxazosinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-464DoxazosinDoxazosinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-464DoxazosinDoxazosinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-465DoxazosinDoxazosinLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-465DoxazosinDoxazosinLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-9675DoxazosinDoxazosinPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8725ORIG2004-06-02
8724ORIG2000-10-18