FDA.reportPublic FDA data

Application 065412

Type
ANDA
Sponsor
YUNG SHIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFACLORCEFACLORFOR SUSPENSION;ORALEQ 125MG BASE/5MLNoNo
002CEFACLORCEFACLORFOR SUSPENSION;ORALEQ 187MG BASE/5MLNoNo
003CEFACLORCEFACLORFOR SUSPENSION;ORALEQ 250MG BASE/5MLNoNo
004CEFACLORCEFACLORFOR SUSPENSION;ORALEQ 375MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-070CefaclorCefaclorPack Pharmaceuticals, LLCANDACurrent
16571-071CefaclorCefaclorPack Pharmaceuticals, LLCANDACurrent
16571-072CefaclorCefaclorPack Pharmaceuticals, LLCANDACurrent
23594-125CefaclorcefaclorCerecor, Inc.ANDACurrent
23594-125CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-125CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-125CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-125CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-125CefaclorcefaclorZylera Pharmaceuticals, LANDACurrent
23594-250CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-250CefaclorcefaclorZylera Pharmaceuticals, LANDACurrent
23594-250CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-250CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-250CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-250CefaclorcefaclorCerecor, Inc.ANDACurrent
23594-375CefaclorcefaclorCerecor, Inc.ANDACurrent
23594-375CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-375CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-375CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-375CefaclorcefaclorAytu Therapeutics, LLCANDACurrent
23594-375CefaclorcefaclorZylera Pharmaceuticals, LANDACurrent
61442-173CefaclorCefaclorCarlsbad Technology, Inc.ANDACurrent
61442-174CefaclorCefaclorCarlsbad Technology, Inc.ANDACurrent
61442-175CefaclorCefaclorCarlsbad Technology, Inc.ANDACurrent
61442-176CefaclorCefaclorCarlsbad Technology, Inc.ANDACurrent
81948-6250CefaclorcefaclorAzorian Pharma, LLCANDACurrent