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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

Biocon Pharma Inc.

DUNS: 080000063

Effective Date

January 4, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Prazosin(1 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Appco Pharma LLC

DUNS Number

078510186

Manufacturing Establishments1

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

Appco Pharma LLC

Labeler

Biocon Pharma Inc.

Registrant

Appco Pharma LLC

DUNS Number

078510186

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

70377-066

Application Number

ANDA213406

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 4, 2023

Ingredients

Code: X0Z7454B90Class: ACTIMQuantity: 1 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

Prazosin hydrochloride

Product Details

NDC Product Code

70377-068

Application Number

ANDA213406

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 4, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Code: X0Z7454B90Class: ACTIMQuantity: 5 mg in 1 1

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Prazosin hydrochloride

Product Details

NDC Product Code

70377-067

Application Number

ANDA213406

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 4, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Code: X0Z7454B90Class: ACTIMQuantity: 2 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

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