Details for New Drug Application (NDA): 078457
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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. Five 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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