Details for New Drug Application (NDA): 078450
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NDA 078450 describes QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Norvium Bioscience, and Sun Pharm Inds Ltd, and is included in six NDAs. It is available from four suppliers. Additional details are available on the QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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 078450
| Tradename: | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | hydrochlorothiazide; quinapril hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078450
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 078450
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 078450 | ANDA | Aurobindo Pharma Limited | 65862-161 | 65862-161-90 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-161-90) |
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 078450 | ANDA | Aurobindo Pharma Limited | 65862-162 | 65862-162-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-162-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;EQ 10MG BASE | ||||
| Approval Date: | Aug 24, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;EQ 20MG BASE | ||||
| Approval Date: | Aug 24, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;EQ 20MG BASE | ||||
| Approval Date: | Aug 24, 2007 | TE: | AB | RLD: | No | ||||
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