FDA.reportPublic FDA data

Application 062791

Type
ANDA
Sponsor
SUN PHARM INDS (IN)

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 250MG BASENoNo
002CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-057cephalexincephalexinBlenheim Pharmacal, Inc.ANDACurrent
33261-020cephalexincephalexinAidarex Pharmaceuticals LLCANDACurrent
33261-149cephalexincephalexinAidarex Pharmaceuticals LLCANDACurrent
42254-080cephalexincephalexinRebel Distributors CorpANDACurrent
42254-197cephalexincephalexinRebel Distributors CorpANDACurrent
50090-0078cephalexincephalexinA-S Medication Solutions LLCANDACurrent
50436-0117cephalexincephalexinUnit Dose ServicesANDACurrent
50436-7216cephalexincephalexinUnit Dose ServicesANDACurrent
53808-0622cephalexincephalexinState of Florida DOH Central PharmacyANDACurrent
61919-051CEPHALEXINCEPHALEXINDIRECT RXANDACurrent
62756-293cephalexincephalexinSun Pharmaceutical Industries LimitedANDACurrent
62756-294cephalexincephalexinSun Pharmaceutical Industries LimitedANDACurrent
68788-9752cephalexincephalexinPreferred Pharmaceuticals, Inc.ANDACurrent