FDA.report

Application 078384

Type
ANDA
Sponsor
BEXIMCO USA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CARVEDILOLCARVEDILOLTABLET;ORAL3.125MGNoNo
002CARVEDILOLCARVEDILOLTABLET;ORAL6.25MGNoNo
003CARVEDILOLCARVEDILOLTABLET;ORAL12.5MGNoNo
004CARVEDILOLCARVEDILOLTABLET;ORAL25MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-633CarvedilolCarvedilolMarlex Pharmaceuticals IncANDACurrent
10135-633CarvedilolCarvedilolMarlex Pharmaceuticals IncANDACurrent
10135-634CarvedilolCarvedilolMarlex Pharmaceuticals IncANDACurrent
10135-634CarvedilolCarvedilolMarlex Pharmaceuticals IncANDACurrent
10135-635CarvedilolCarvedilolMarlex Pharmaceuticals IncANDACurrent
10135-635CarvedilolCarvedilolMarlex Pharmaceuticals IncANDACurrent
10135-637CarvedilolCarvedilolMarlex Pharmaceuticals IncANDACurrent
10135-637CarvedilolCarvedilolMarlex Pharmaceuticals IncANDACurrent
43547-254CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-254CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-254CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-255CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-255CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-255CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-256CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-256CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-256CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-257CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-257CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
43547-257CarvedilolCarvedilolSolco Healthcare US LLCANDACurrent
51407-039CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-039CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-039CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-039CarvedilolCarvedilolGolden State Medical Supply Inc.ANDACurrent
51407-039CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-040CarvedilolCarvedilolGolden State Medical Supply Inc.ANDACurrent
51407-040CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-040CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-040CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-040CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-041CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-041CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-041CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-041CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-041CarvedilolCarvedilolGolden State Medical Supply Inc.ANDACurrent
51407-042CarvedilolCarvedilolGolden State Medical Supply Inc.ANDACurrent
51407-042CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-042CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-042CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51407-042CarvedilolCarvedilolGolden State Medical Supply, Inc.ANDACurrent
51655-943CarvedilolCarvedilolNorthwind PharmaceuticalsANDACurrent
53808-1024CarvedilolCarvedilolState of Florida DOH Central PharmacyANDACurrent
55700-819CarvedilolCarvedilolQuality Care Products, LLCANDACurrent
55700-819CarvedilolCarvedilolQuality Care Products, LLCANDACurrent
60760-376CarvedilolCarvedilolSt. Mary's Medical Park PharmacyANDACurrent
61919-533CARVEDILOLCARVEDILOLDIRECT RXANDACurrent
61919-533CARVEDILOLCARVEDILOLDIRECT RXANDACurrent
68071-2633CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5275CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5275CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7883CarvedilolCarvedilolPreferred Pharmacdeuticals IncANDACurrent
68788-7883CarvedilolCarvedilolPreferred Pharmacdeuticals IncANDACurrent
70518-0564CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0564CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1797CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1797CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70934-874CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-910CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-910CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-910CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1407CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-1407CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-1457CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-1457CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-1813CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-1813CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71610-062CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-063CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-066CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-067CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
76385-110CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-110CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-110CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-110CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-110CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-111CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-111CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-111CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-111CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent
76385-111CarvedilolCarvedilolBayshore Pharmaceuticals LLCANDACurrent

Documents

DocumentSubmission typeDate
9153ORIG2007-09-07