MedPath
FDA Approval

Terazosin Hydrochloride

February 19, 2020

HUMAN PRESCRIPTION DRUG LABEL

Terazosin(5 mg in 1 1)

Manufacturing Establishments (1)

A-S Medication Solutions

A-S Medication Solutions

830016429

Products (2)

Terazosin Hydrochloride

50090-1943

ANDA074823

ANDA (C73584)

ORAL

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

50090-0659

ANDA074823

ANDA (C73584)

ORAL

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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