Details for New Drug Application (NDA): 076803
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The generic ingredient in QUINAPRIL HYDROCHLORIDE is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
Summary for 076803
Tradename: | QUINAPRIL HYDROCHLORIDE |
Applicant: | Chartwell Rx |
Ingredient: | quinapril hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076803
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Suppliers and Packaging for NDA: 076803
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 076803 | ANDA | Chartwell RX, LLC | 62135-484 | 62135-484-60 | 60 TABLET, FILM COATED in 1 BOTTLE (62135-484-60) |
QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 076803 | ANDA | Chartwell RX, LLC | 62135-485 | 62135-485-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-485-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Mar 2, 2005 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 2, 2005 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Mar 2, 2005 | TE: | RLD: | No |
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