Details for New Drug Application (NDA): 020125
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NDA 020125 describes ACCURETIC, which is a drug marketed by Pfizer Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ACCURETIC profile page.
The generic ingredient in ACCURETIC is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
The generic ingredient in ACCURETIC is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
Summary for 020125
| Tradename: | ACCURETIC |
| Applicant: | Pfizer Pharms |
| Ingredient: | hydrochlorothiazide; quinapril hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020125
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 020125
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACCURETIC | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 020125 | NDA | Parke-Davis Div of Pfizer Inc | 0071-3112 | 0071-3112-23 | 90 TABLET, FILM COATED in 1 BOTTLE (0071-3112-23) |
| ACCURETIC | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 020125 | NDA | Parke-Davis Div of Pfizer Inc | 0071-5212 | 0071-5212-23 | 90 TABLET, FILM COATED in 1 BOTTLE (0071-5212-23) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 28, 1999 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 28, 1999 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 28, 1999 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020125
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Pharms | ACCURETIC | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 020125-003 | Dec 28, 1999 | 4,344,949*PED | ⤷ Subscribe |
| Pfizer Pharms | ACCURETIC | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 020125-001 | Dec 28, 1999 | 4,344,949*PED | ⤷ Subscribe |
| Pfizer Pharms | ACCURETIC | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 020125-003 | Dec 28, 1999 | 4,743,450*PED | ⤷ Subscribe |
| Pfizer Pharms | ACCURETIC | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 020125-002 | Dec 28, 1999 | 4,743,450*PED | ⤷ Subscribe |
| Pfizer Pharms | ACCURETIC | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 020125-002 | Dec 28, 1999 | 4,344,949*PED | ⤷ Subscribe |
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