Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Clinical Solutions Wholesale, LLC
078710347
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Clinical Solutions Wholesale, LLC
Clinical Solutions Wholesale, LLC
Clinical Solutions Wholesale, LLC
078710347
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tamsulosin Hydrochloride
Product Details
NDC Product Code
58118-0598Application Number
ANDA202433Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 25, 2020PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
TamsulosinActive
Code: 11SV1951MRClass: ACTIBQuantity: 0.4 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT