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Doxazosin

Doxazosin Tablets, USP Rx only These highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. Initial U.S. Approval: 1990

Approved
Approval ID

de9ab9a4-d8b8-8b36-e053-2a95a90aaa35

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 9, 2022

Manufacturers
FDA

AvPAK

DUNS: 832926666

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Doxazosin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-224
Application NumberANDA075580
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2022
FDA Product Classification

INGREDIENTS (5)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 4 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM

Doxazosin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-223
Application NumberANDA075580
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2022
FDA Product Classification

INGREDIENTS (5)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 2 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM

Doxazosin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-222
Application NumberANDA075580
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2022
FDA Product Classification

INGREDIENTS (5)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 1 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Doxazosin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-225
Application NumberANDA075580
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2022
FDA Product Classification

INGREDIENTS (5)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 8 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Doxazosin - FDA Drug Approval Details