FDA.reportPublic FDA data

Application 203653

Type
ANDA
Sponsor
RITEDOSE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.0103% BASENoNo
002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.021% BASENoNo
003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.042% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-9930LevalbuterolLevalbuterol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9930LevalbuterolLevalbuterol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9930LevalbuterolLevalbuterol HydrochlorideImpax GenericsANDACurrent
0115-9931LevalbuterolLevalbuterol HydrochlorideImpax GenericsANDACurrent
0115-9931LevalbuterolLevalbuterol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9931LevalbuterolLevalbuterol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9932LevalbuterolLevalbuterol HydrochlorideImpax GenericsANDACurrent
0115-9932LevalbuterolLevalbuterol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9932LevalbuterolLevalbuterol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0378-9690LevalbuterolLevalbuterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9690LevalbuterolLevalbuterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9691LevalbuterolLevalbuterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9691LevalbuterolLevalbuterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9692LevalbuterolLevalbuterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9692LevalbuterolLevalbuterolMylan Pharmaceuticals Inc.ANDACurrent
35573-443LevalbuterolLevalbuterol HydrochlorideBurel Pharmaceuticals, Inc.ANDACurrent
35573-443LevalbuterolLevalbuterol HydrochlorideBurel Pharmaceuticals, LLCANDACurrent
35573-444LevalbuterolLevalbuterol HydrochlorideBurel Pharmaceuticals, Inc.ANDACurrent
35573-444LevalbuterolLevalbuterol HydrochlorideBurel Pharmaceuticals, LLCANDACurrent
35573-445LevalbuterolLevalbuterol HydrochlorideBurel Pharmaceuticals, Inc.ANDACurrent
35573-445LevalbuterolLevalbuterol HydrochlorideBurel Pharmaceuticals, LLCANDACurrent
68071-5027LevalbuterolLevalbuterol HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5027LevalbuterolLevalbuterol HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals,ANDACurrent
76204-700LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-800LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals,ANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals,ANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent
76204-900LevalbuterolLevalbuterol HydrochlorideRitedose Pharmaceuticals, LLCANDACurrent