Details for New Drug Application (NDA): 201356
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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 201356
Tradename: | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
Applicant: | Invagen Pharms |
Ingredient: | hydrochlorothiazide; quinapril hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201356
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 201356
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 201356 | ANDA | Cipla USA Inc. | 69097-828 | 69097-828-05 | 90 TABLET in 1 BOTTLE (69097-828-05) |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; quinapril hydrochloride | TABLET;ORAL | 201356 | ANDA | Cipla USA Inc. | 69097-829 | 69097-829-05 | 90 TABLET in 1 BOTTLE (69097-829-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;EQ 10MG BASE | ||||
Approval Date: | Apr 20, 2011 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;EQ 20MG BASE | ||||
Approval Date: | Apr 20, 2011 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;EQ 20MG BASE | ||||
Approval Date: | Apr 20, 2011 | TE: | RLD: | No |
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