MedPath
FDA Product

Tamsulosin Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Tamsulosin Hydrochloride

68084-299

Regulatory Information

68084-299

ANDA078225

C73584

October 24, 2023

USA

These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN hydrochloride capsules USP, for oral use Initial U.S. Approval: 1997

HUMAN PRESCRIPTION DRUG LABEL

9

Company Information

929561009

Active Ingredients

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

METHACRYLIC ACID

Code: 1CS02G8656

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TAMSULOSIN HYDROCHLORIDE

Quantity: 0.4 mg in 1 1

Code: 11SV1951MR

Class Code: ACTIB

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

TAMSULOSIN

Code: G3P28OML5I

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