MedPath

Doxazosin

DOXAZOSIN MESYLATE 4MG TAB FOR MYLAN

Approved
Approval ID

dc9b589b-d6ce-4780-9de4-3d95a30f44ba

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 30, 2013

Manufacturers
FDA

Aidarex Pharmaceuticals LLC

DUNS: 801503249

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 Code33261-658
Application NumberANDA075509
Product Classification
M
Marketing Category
C73584
G
Generic Name
doxazosin mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2013
FDA Product Classification

INGREDIENTS (8)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 4 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT

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Doxazosin - FDA Drug Approval Details