FDA.reportPublic FDA data

Application 065234

Type
ANDA
Sponsor
LUPIN

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
33261-485cephalexinCephalexinAidarex Pharmaceuticals LLCANDACurrent
52959-620CephalexinCephalexinH.J. Harkins Company, Inc.ANDACurrent
55700-149cephalexinCephalexinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-656cephalexinCephalexinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-656cephalexinCephalexinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-656cephalexinCephalexinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-049CEPHALEXINCEPHALEXINDIRECT RXANDACurrent
61919-049CEPHALEXINCEPHALEXINDIRECT RXANDACurrent
68071-5011cephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5011cephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68180-123cephalexinCephalexinLupin Pharmaceuticals, Inc.ANDACurrent
68180-124cephalexinCephalexinLupin Pharmaceuticals, Inc.ANDACurrent
68180-440cephalexinCephalexinLupin Pharmaceuticals, Inc.ANDACurrent
68180-440cephalexinCephalexinLupin Pharmaceuticals, Inc.ANDACurrent
68180-441cephalexinCephalexinLupin Pharmaceuticals, Inc.ANDACurrent
68180-441cephalexinCephalexinLupin Pharmaceuticals, Inc.ANDACurrent
68788-7938cephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7938cephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9956cephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9957cephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
71205-553cephalexinCephalexinProficient Rx LPANDACurrent