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FDA Drug information

Tamsulosin Hydrochloride

Read time: 1 mins
Marketing start date: 22 Jul 2024

Summary of product characteristics


Effective Time

20221031

Version

8

Spl Product Data Elements

Tamsulosin Hydrochloride Tamsulosin Hydrochloride TAMSULOSIN HYDROCHLORIDE TAMSULOSIN D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 FERRIC OXIDE YELLOW METHACRYLIC ACID POLYSORBATE 80 GELATIN TALC TITANIUM DIOXIDE TRIACETIN FERROSOFERRIC OXIDE CELLULOSE, MICROCRYSTALLINE GREEN PEACH CAPSULE ZA;18;0;4mg

Application Number

ANDA078225

Brand Name

Tamsulosin Hydrochloride

Generic Name

Tamsulosin Hydrochloride

Product Ndc

65841-695

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-695-01 in bottle of 100 Capsules Tamsulosin Hydrochloride Capsules USP, 0.4 mg R x only 100 Capsules tamsulosin hcl capsules, 0.4 mg

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