FDA.reportPublic FDA data

Application 210221

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINFOR SUSPENSION;ORALEQ 125MG BASE/5MLNoNo
002CEPHALEXINCEPHALEXINFOR SUSPENSION;ORALEQ 250MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4795CephalexinCephalexinA-S Medication SolutionsANDACurrent
50090-5196CephalexinCephalexinA-S Medication SolutionsANDACurrent
55700-841CephalexinCephalexinQuality Care Products, LLCANDACurrent
55700-841CephalexinCephalexinQuality Care Products, LLCANDACurrent
63629-8857CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8857CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8857CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8858CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8858CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-8858CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9204CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9204CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9204CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9205CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9205CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9205CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9206CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9206CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9206CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9207CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9207CephalexinCephalexinBryant Ranch PrepackANDACurrent
63629-9207CephalexinCephalexinBryant Ranch PrepackANDACurrent
67877-544CephalexinCephalexinAscend Laboratories, LLCANDACurrent
67877-544CephalexinCephalexinAscend Laboratories, LLCANDACurrent
67877-545CephalexinCephalexinAscend Laboratories, LLCANDACurrent
67877-545CephalexinCephalexinAscend Laboratories, LLCANDACurrent
68071-2246CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2246CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2889CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5038CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5038CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5038CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7529CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7529CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7529CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7796CephalexinCephalexinPreferred Pharmaceuticlas Inc.ANDACurrent
68788-7796CephalexinCephalexinPreferred Pharmaceuticlas Inc.ANDACurrent
68788-7796CephalexinCephalexinPreferred Pharmaceuticlas Inc.ANDACurrent