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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
Effective Date
February 19, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Terazosin(5 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products2

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
50090-1943
Application Number
ANDA074823
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 28, 2019
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TerazosinActive
Code: D32S14F082Class: ACTIMQuantity: 5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Terazosin Hydrochloride

Product Details

NDC Product Code
50090-0659
Application Number
ANDA074823
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 28, 2019
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TerazosinActive
Code: D32S14F082Class: ACTIMQuantity: 10 mg in 1 1
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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