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FDA Approval

PRAZOSIN HYDROCHLORIDE

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

FDA Approval Summary

Company

Alembic Pharmaceuticals Inc.

DUNS: 079288842

Effective Date

May 12, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Prazosin(1 mg in 1 1)

Manufacturing Establishments1

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

Alembic Pharmaceuticals Limited

Labeler

Alembic Pharmaceuticals Inc.

DUNS Number

650574671

Products3

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

PRAZOSIN HYDROCHLORIDE

Product Details

NDC Product Code

62332-691

Application Number

ANDA217268

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 12, 2023

Ingredients

Code: X0Z7454B90Class: ACTIMQuantity: 1 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PRAZOSIN HYDROCHLORIDE

Product Details

NDC Product Code

62332-692

Application Number

ANDA217268

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 12, 2023

Ingredients

Code: X0Z7454B90Class: ACTIMQuantity: 2 mg in 1 1

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

PRAZOSIN HYDROCHLORIDE

Product Details

NDC Product Code

62332-693

Application Number

ANDA217268

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 12, 2023

Ingredients

Code: X0Z7454B90Class: ACTIMQuantity: 5 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

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