Details for New Drug Application (NDA): 076674
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NDA 076674 describes LISINOPRIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo, Chartwell Rx, Corepharma, Epic Pharma Llc, Hikma Intl Pharms, Invagen Pharms, Lupin, Pharmobedient, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the LISINOPRIL AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in LISINOPRIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
The generic ingredient in LISINOPRIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 076674
| Tradename: | LISINOPRIL AND HYDROCHLOROTHIAZIDE |
| Applicant: | Corepharma |
| Ingredient: | hydrochlorothiazide; lisinopril |
| Patents: | 0 |
Pharmacology for NDA: 076674
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 076674
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; lisinopril | TABLET;ORAL | 076674 | ANDA | GSMS, Incorporated | 51407-564 | 51407-564-05 | 500 TABLET in 1 BOTTLE (51407-564-05) |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; lisinopril | TABLET;ORAL | 076674 | ANDA | GSMS, Incorporated | 51407-564 | 51407-564-90 | 90 TABLET in 1 BOTTLE (51407-564-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;10MG | ||||
| Approval Date: | Oct 5, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
| Approval Date: | Oct 5, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;20MG | ||||
| Approval Date: | Oct 5, 2004 | TE: | AB | RLD: | No | ||||
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