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FDA Approval

Terazosin

CompanyAvPAK (DUNS: 832926666)

Effective Date

May 6, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Terazosin(10 mg in 1 1)

Products (4)

Terazosin

NDC Product Code

50268-767

Application Number

ANDA075317

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 6, 2022

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 10 mg in 1 1

Terazosin

NDC Product Code

50268-766

Application Number

ANDA075317

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 6, 2022

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 5 mg in 1 1

Terazosin

NDC Product Code

50268-765

Application Number

ANDA075317

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 6, 2022

Ingredients

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 2 mg in 1 1

Terazosin

NDC Product Code

50268-764

Application Number

ANDA075317

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 6, 2022

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 1 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

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