FDA.reportPublic FDA data

Application 210907

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL10MGNoNo
003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL15MGNoNo
004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-244Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-244Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-244Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-245Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-245Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-245Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-246Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-246Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-246Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-247Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-247Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-247Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-5762Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
50090-5797Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
55700-869Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
55700-869Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
55700-869Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
55700-869Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
68071-2572Buspirone HydrochlorideBuspirone HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7952Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7952Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7968Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7968Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8086Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8086Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-2803Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2803Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3091Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3091Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3091Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3279Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3279Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1673Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1749Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1749Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1924Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-2060Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
72189-235Buspirone HclBuspirone HclDirect RxANDACurrent
72189-235Buspirone HclBuspirone HclDirect RxANDACurrent
72189-235Buspirone HclBuspirone HclDirect RxANDACurrent