Details for New Drug Application (NDA): 205823
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NDA 205823 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, Norvium Bioscience, Prinston Inc, Sun Pharm Inds Ltd, Apotex, and Aurobindo Pharma, and is included in nineteen NDAs. It is available from nine 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
Summary for 205823
| Tradename: | QUINAPRIL HYDROCHLORIDE |
| Applicant: | Prinston Inc |
| Ingredient: | quinapril hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205823
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Suppliers and Packaging for NDA: 205823
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 205823 | ANDA | Solco Healthcare US, LLC | 43547-410 | 43547-410-09 | 90 TABLET in 1 BOTTLE (43547-410-09) |
| QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 205823 | ANDA | Solco Healthcare US, LLC | 43547-411 | 43547-411-09 | 90 TABLET in 1 BOTTLE (43547-411-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Sep 15, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Sep 15, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Sep 15, 2016 | TE: | AB | RLD: | No | ||||
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