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Doxazosin

These highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS.DOXAZOSIN tablets, for oral useInitial U.S. Approval: 1990

Approved
Approval ID

57f4a953-ad23-4a44-9956-c48aa5927132

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 12, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-6401
Application NumberANDA075536
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2021
FDA Product Classification

INGREDIENTS (7)

DOXAZOSIN MESYLATEActive
Quantity: 2 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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Doxazosin - FDA Drug Approval Details