Doxazosin Mesylate
DOXAZOSIN MESYLATE TABLETS These highlights do not include all the information needed to use DOXAZOSIN MESYLATE TABLETS safely and effectively. See full prescribing information for DOXAZOSIN MESYLATE TABLETS. DOXAZOSIN MESYLATE tablets, for oral use Initial U.S. Approval: 1990
Approved
Approval ID
80dbf08b-e522-43ca-9575-5db446528252
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2019
Manufacturers
FDA
DOH CENTRAL PHARMACY
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxazosin Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-1107
Application NumberANDA076161
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2019
FDA Product Classification
INGREDIENTS (8)
DOXAZOSIN MESYLATEActive
Quantity: 4 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT