Tamsulosin Hydrochloride
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, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
a6a285de-bb2c-aa42-e053-2a95a90a1ce8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2020
Manufacturers
FDA
Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
DUNS: 547688780
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tamsulosin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60723-056
Application NumberANDA211885
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tamsulosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2020
FDA Product Classification
INGREDIENTS (9)
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 1
Code: 11SV1951MR
Classification: ACTIB
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT