FDA.reportPublic FDA data

Application 202843

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6808MontelukastMontelukastMajor PharmaceuticalsANDACurrent
0904-6808MontelukastMontelukastMajor PharmaceuticalsANDACurrent
0904-6808MontelukastMontelukastMajor PharmaceuticalsANDACurrent
31722-726MontelukastMontelukastCamber Pharmaceuticals, Inc.ANDACurrent
31722-726MontelukastMontelukastCamber Pharmaceuticals, Inc.ANDACurrent
31722-726MontelukastMontelukastCamber Pharmaceuticals, Inc.ANDACurrent
50090-6108MontelukastMontelukastA-S Medication SolutionsANDACurrent
50268-556MontelukastMontelukastAvPAKANDACurrent
50268-556MontelukastMontelukastAvPAKANDACurrent
55154-8075MontelukastMontelukastCardinal HealthANDACurrent
55154-8075MontelukastMontelukastCardinal Health 107, LLCANDACurrent
55154-8075MontelukastMontelukastCardinal HealthANDACurrent
68071-1561MontelukastMontelukastNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2425MontelukastMontelukastNuCare Pharmaceuticals,Inc.ANDACurrent
68645-560MontelukastMontelukastLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-560MontelukastMontelukastLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-560MontelukastMontelukastLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-560MontelukastMontelukastLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-8099MontelukastMontelukastPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8099MontelukastMontelukastPreferred Pharmaceuticals, Inc.ANDACurrent
70518-3133MontelukastMontelukastREMEDYREPACK INC.ANDACurrent
70518-3133MontelukastMontelukastREMEDYREPACK INC.ANDACurrent
70518-3133MontelukastMontelukastREMEDYREPACK INC.ANDACurrent
71335-1979MontelukastMontelukastBryant Ranch PrepackANDACurrent
71335-1979MontelukastMontelukastBryant Ranch PrepackANDACurrent
71610-563MontelukastMontelukastAphena Pharma Solutions - Tennessee, LLCANDACurrent
72865-175MontelukastMontelukastXLCare Pharmaceuticals Inc.ANDACurrent
82009-009MontelukastMontelukastQuallent Pharmaceuticals Health LLCANDACurrent