Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

prazosin hydrochloride

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

FDA Approval Summary

Company

Novadoz Pharmaceuticals LLC

DUNS: 081109687

Effective Date

April 16, 2025

Labeling Type

Human Prescription Drug Label

Active Ingredients

Prazosin(2 mg in 1 1)

Manufacturing Establishments1

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

MSN LABORATORIES PRIVATE LIMITED

Labeler

Novadoz Pharmaceuticals LLC

DUNS Number

650786952

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

72205-276

Application Number

ANDA216727

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 16, 2025

Ingredients

Code: X0Z7454B90Class: ACTIMQuantity: 2 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

prazosin hydrochloride

Product Details

NDC Product Code

72205-275

Application Number

ANDA216727

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 16, 2025

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Code: X0Z7454B90Class: ACTIMQuantity: 1 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

prazosin hydrochloride

Product Details

NDC Product Code

72205-277

Application Number

ANDA216727

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 16, 2025

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Code: X0Z7454B90Class: ACTIMQuantity: 5 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESCRIPTION SECTION

CLINICAL PHARMACOLOGY SECTION

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION

CONTRAINDICATIONS SECTION

WARNINGS SECTION

PRECAUTIONS SECTION

ADVERSE REACTIONS SECTION

OVERDOSAGE SECTION

HOW SUPPLIED SECTION

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy