FDA.reportPublic FDA data

Application 062713

Type
ANDA
Sponsor
BELCHER PHARMS

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
10544-082CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
10544-868CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
10544-945CephalexincephalexinBlenheim Pharmacal, Inc.ANDACurrent
10544-946CephalexincephalexinBlenheim Pharmacal, Inc.ANDACurrent
15749-801CephalexinCephalexinAmerican Antibiotics, IncANDACurrent
15749-802CephalexinCephalexinAmerican Antibiotics, IncANDACurrent
42291-208CephalexinCephalexinAvKARE, Inc.ANDACurrent
42291-208CephalexinCephalexinAvKARE, Inc.ANDACurrent
42291-208CephalexinCephalexinAvKAREANDACurrent
42291-209CephalexinCephalexinAvKARE, Inc.ANDACurrent
42291-209CephalexinCephalexinAvKARE, Inc.ANDACurrent
42291-209CephalexinCephalexinAvKAREANDACurrent
42582-211CephalexinCephalexinBi-Coastal Pharma International LLCANDACurrent
42582-211CephalexinCephalexinBi-Coastal Pharma International LLCANDACurrent
42582-211CephalexinCephalexinBi-Coastal Pharma International LLCANDACurrent
42582-212CephalexinCephalexinBi-Coastal Pharma International LLCANDACurrent
42582-212CephalexinCephalexinBi-Coastal Pharma International LLCANDACurrent
42582-212CephalexinCephalexinBi-Coastal Pharma International LLCANDACurrent
50090-0084CephalexinCephalexinA-S Medication Solutions LLCANDACurrent
50436-1020CephalexincephalexinUnit Dose ServicesANDACurrent
51655-025CephalexinCephalexinNorthwind PharmaceuticalsANDACurrent
55700-009CephalexinCephalexinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-364CephalexincephalexinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-029CEPHALEXINCEPHALEXINDIRECT RXANDACurrent
61919-522CEPHALEXINCEPHALEXINDirectRXANDACurrent
61919-522CEPHALEXINCEPHALEXINDIRECT RXANDACurrent
61919-522CEPHALEXINCEPHALEXINDIRECT RXANDACurrent
62250-801CephalexinCephalexinBelcher Pharmaceuticals, LLCANDACurrent
62250-801CephalexinCephalexinBelcher Pharmaceuticals, LLCANDACurrent
62250-802CephalexinCephalexinBelcher Pharmaceuticals, LLCANDACurrent
62250-802CephalexinCephalexinBelcher Pharmaceuticals, LLCANDACurrent
63187-287CephalexinCephalexinProficient Rx LPANDACurrent
63187-454CephalexinCephalexinProficient Rx LPANDACurrent
64205-101CephalexinCephalexinReadyMedsANDACurrent
64205-102CephalexinCephalexinReadyMedsANDACurrent
64725-0101CephalexinCephalexinTYA PharmaceuticalsANDACurrent
64725-1021CephalexinCephalexinTYA PharmaceuticalsANDACurrent
67296-1211CephalexinCephalexinRedPharm Drug, Inc.ANDACurrent
67296-1211CephalexinCephalexinRedPharm Drug, Inc.ANDACurrent
67296-1362CephalexinCephalexinRedPharm Drug, Inc.ANDACurrent
67296-1362CephalexinCephalexinRedPharm Drug, Inc.ANDACurrent
68788-8994CephalexincephalexinPreferred Pharmaceuticals Inc.ANDACurrent
69543-102CephalexincephalexinVirtus PharmaceuticalsANDACurrent
69543-102CephalexincephalexinVirtus PharmaceuticalsANDACurrent
69543-102CephalexincephalexinVirtus PharmaceuticalsANDACurrent