Details for New Drug Application (NDA): 078457
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NDA 078457 describes QUINAPRIL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Lupin, Mylan, Pharmobedient, Prinston Inc, Sun Pharm Inds Ltd, Apotex, and Aurobindo Pharma, and is included in nineteen NDAs. It is available from eight suppliers. Additional details are available on the QUINAPRIL HYDROCHLORIDE profile page.
The generic ingredient in QUINAPRIL HYDROCHLORIDE is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
The generic ingredient in QUINAPRIL HYDROCHLORIDE is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
Summary for 078457
| Tradename: | QUINAPRIL HYDROCHLORIDE |
| Applicant: | Invagen Pharms |
| Ingredient: | quinapril hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078457
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Suppliers and Packaging for NDA: 078457
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 078457 | ANDA | Proficient Rx LP | 63187-425 | 63187-425-30 | 30 TABLET in 1 BOTTLE (63187-425-30) |
| QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 078457 | ANDA | Proficient Rx LP | 63187-425 | 63187-425-60 | 60 TABLET in 1 BOTTLE (63187-425-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 24, 2007 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 24, 2007 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Aug 24, 2007 | TE: | RLD: | No | |||||
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