Application 204645

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDECAPSULE;ORAL0.4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-159Tamsulosin HydrochlorideTamsulosin HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-159Tamsulosin HydrochlorideTamsulosin HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-159Tamsulosin HydrochlorideTamsulosin HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
60760-450Tamsulosin HydrochlorideTamsulosin HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
67296-1739Tamsulosin HydrochlorideTamsulosin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1739Tamsulosin HydrochlorideTamsulosin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1739Tamsulosin HydrochlorideTamsulosin HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-1840Tamsulosin HydrochlorideTamsulosin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4872Tamsulosin HydrochlorideTamsulosin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4872Tamsulosin HydrochlorideTamsulosin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7780Tamsulosin HydrochlorideTamsulosin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7780Tamsulosin HydrochlorideTamsulosin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7780Tamsulosin HydrochlorideTamsulosin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2541Tamsulosin HydrochlorideTamsulosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2541Tamsulosin HydrochlorideTamsulosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2541Tamsulosin HydrochlorideTamsulosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2541Tamsulosin HydrochlorideTamsulosin HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46986ORIG2017-01-27