FDA.reportPublic FDA data

Application 204010

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6570Oxybutynin ChlorideOxybutynin ChlorideMajor PharmaceuticalsANDACurrent
0904-6570Oxybutynin ChlorideOxybutynin ChlorideMajor PharmaceuticalsANDACurrent
0904-6570Oxybutynin ChlorideOxybutynin ChlorideMajor PharmaceuticalsANDACurrent
0904-6570Oxybutynin ChlorideOxybutynin ChlorideMajor PharmaceuticalsANDACurrent
10135-609Oxybutynin ChlorideOxybutynin ChlorideMarlex Pharmaceuticals IncANDACurrent
10135-609Oxybutynin ChlorideOxybutynin ChlorideMarlex Pharmaceuticals IncANDACurrent
10135-610Oxybutynin ChlorideOxybutynin ChlorideMarlex Pharmaceuticals IncANDACurrent
10135-610Oxybutynin ChlorideOxybutynin ChlorideMarlex Pharmaceuticals IncANDACurrent
10135-611Oxybutynin ChlorideOxybutynin ChlorideMarlex Pharmaceuticals IncANDACurrent
10135-611Oxybutynin ChlorideOxybutynin ChlorideMarlex Pharmaceuticals IncANDACurrent
50090-4658Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4658Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4658Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4728Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4728Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4728Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
65162-371Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-371Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-371Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-371Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-371Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-372Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-372Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-372Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-372Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-372Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-373Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-373Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-373Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-373Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
65162-373Oxybutynin ChlorideOxybutynin ChlorideAmneal Pharmaceuticals LLCANDACurrent
71610-347Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent