FDA.report

Application 077309

Type
ANDA
Sponsor
APOTEX INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIRTABLET;ORAL400MGNoNo
002ACYCLOVIRACYCLOVIRTABLET;ORAL800MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7033acycloviracyclovirLiberty Pharmaceuticals, Inc.ANDACurrent
0904-5790acycloviracyclovirMajor PharmaceuticalsANDACurrent
0904-5790acycloviracyclovirMajor PharmaceuticalsANDACurrent
0904-5790acycloviracyclovirMajor PharmaceuticalsANDACurrent
0904-5790acycloviracyclovirMajor PharmaceuticalsANDACurrent
12634-697acycloviracyclovirApotheca Inc.ANDACurrent
35356-903AcycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-903AcycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-903AcycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-903AcycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
43353-933AcycloviracyclovirAphena Pharma Solutions - Tennessee, LLCANDACurrent
49999-231acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0637acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-0637acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-0642acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-0643acycloviracyclovirA-S Medication SolutionsANDACurrent
60429-309acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60429-309acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60429-309acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60429-310acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60429-310acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60505-5306acycloviracyclovirApotex Corp.ANDACurrent
60505-5307acycloviracyclovirApotex Corp.ANDACurrent
61919-003ACYCLOVIRACYCLOVIRDIRECT RXANDACurrent
61919-003ACYCLOVIRACYCLOVIRDIRECT RXANDACurrent
61919-003ACYCLOVIRACYCLOVIRDIRECT RXANDACurrent
61919-003ACYCLOVIRACYCLOVIRDIRECT RXANDACurrent
63187-192acycloviracyclovirProficient Rx LPANDACurrent
63187-192acycloviracyclovirProficient Rx LPANDACurrent
63629-1192acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-1193acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-9174acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-9174acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-9174acycloviracyclovirBryant Ranch PrepackANDACurrent
67296-1034acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1034acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1034acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1707acycloviracyclovirRedPharm DrugANDACurrent
67296-1707acycloviracyclovirRedPharm DrugANDACurrent
68071-2247acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2247acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2287acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2287acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2287acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5094acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5094acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5100acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5100acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68084-108AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-108AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-108AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-109AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-109AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-109AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68788-6360acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7760acycloviracyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7760acycloviracyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7760acycloviracyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7760acycloviracyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7895acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7895acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-8989acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70934-556acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-556acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-556acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-556acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-557acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-557acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-557acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-694acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-694acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-697acycloviracyclovirApotex Corp.ANDACurrent
71205-391acycloviracyclovirProficient Rx LPANDACurrent
71335-1381acycloviracyclovirBryant Ranch PrepackANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.DateStorage
90350ORIG12005-10-20FDA source fallback