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FDA Approval

Terazosin

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

FDA Approval Summary

Company
Chartwell RX, LLC
DUNS: 079394054
Effective Date
February 9, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Terazosin(10 mg in 1 1)

Products4

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

Terazosin

Product Details

NDC Product Code
62135-461
Application Number
ANDA075614
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACT
TerazosinActive
Code: D32S14F082Class: ACTIMQuantity: 10 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Terazosin

Product Details

NDC Product Code
62135-460
Application Number
ANDA075614
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACT
TerazosinActive
Code: D32S14F082Class: ACTIMQuantity: 5 mg in 1 1

Terazosin

Product Details

NDC Product Code
62135-459
Application Number
ANDA075614
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACT
TerazosinActive
Code: D32S14F082Class: ACTIMQuantity: 2 mg in 1 1

Terazosin

Product Details

NDC Product Code
62135-458
Application Number
ANDA075614
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACT
TerazosinActive
Code: D32S14F082Class: ACTIMQuantity: 1 mg in 1 1
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