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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 use Initial U.S. Approval: 1990

Approved
Approval ID

2830533c-ccdf-4401-b19c-763eeb1bc0a7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 15, 2023

Manufacturers
FDA

Accord Healthcare Inc.

DUNS: 604222237

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 Code16729-415
Application NumberANDA202824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification

INGREDIENTS (5)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 8 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM

Doxazosin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16729-414
Application NumberANDA202824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification

INGREDIENTS (6)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
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 Code16729-213
Application NumberANDA202824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification

INGREDIENTS (6)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
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 Code16729-211
Application NumberANDA202824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification

INGREDIENTS (5)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 1 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM

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