FDA.reportPublic FDA data

Application 206647

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDETABLET;ORALEQ 0.5MG BASENoNo
002ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-123Alosetron HydrochlorideAlosetron HydrochlorideAvKARE, Inc.ANDACurrent
42291-123Alosetron HydrochlorideAlosetron HydrochlorideAvKARE, Inc.ANDACurrent
42291-124Alosetron HydrochlorideAlosetron HydrochlorideAvKARE, Inc.ANDACurrent
65162-248Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-248Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-248Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-248Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-248Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-248Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-249Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-249Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-249Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-249Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-249Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-249Alosetron HydrochlorideAlosetron HydrochlorideAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75379SUPPL 2023-09-08
50041APPL2017-10-12
60819ORIG2016-12-22