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FDA Approval

Terazosin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Golden State Medical Supply, Inc.

DUNS: 603184490

Effective Date

August 8, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Terazosin(2 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Golden State Medical Supply, Inc.

Labeler

Golden State Medical Supply, Inc.

DUNS Number

603184490

Products4

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

Terazosin Hydrochloride

Product Details

NDC Product Code

51407-733

Application Number

ANDA074823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 8, 2023

Ingredients

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 2 mg in 1 1

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

Terazosin Hydrochloride

Product Details

NDC Product Code

51407-734

Application Number

ANDA074823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 8, 2023

Ingredients

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 5 mg in 1 1

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Terazosin Hydrochloride

Product Details

NDC Product Code

51407-732

Application Number

ANDA074823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 8, 2023

Ingredients

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 1 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Terazosin Hydrochloride

Product Details

NDC Product Code

51407-735

Application Number

ANDA074823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 8, 2023

Ingredients

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 10 mg in 1 1

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