Details for New Drug Application (NDA): 077912
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The generic ingredient in LISINOPRIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 077912
Tradename: | LISINOPRIL AND HYDROCHLOROTHIAZIDE |
Applicant: | Lupin |
Ingredient: | hydrochlorothiazide; lisinopril |
Patents: | 0 |
Pharmacology for NDA: 077912
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 077912
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LISINOPRIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; lisinopril | TABLET;ORAL | 077912 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 35356-777 | 35356-777-30 | 30 TABLET in 1 BOTTLE (35356-777-30) |
LISINOPRIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; lisinopril | TABLET;ORAL | 077912 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 35356-777 | 35356-777-90 | 90 TABLET in 1 BOTTLE (35356-777-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;10MG | ||||
Approval Date: | Sep 27, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
Approval Date: | Sep 27, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;20MG | ||||
Approval Date: | Sep 27, 2006 | TE: | AB | RLD: | No |
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