Details for New Drug Application (NDA): 204058
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NDA 204058 describes LISINOPRIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo, Chartwell Rx, Corepharma, Epic Pharma Llc, Hikma Intl Pharms, Invagen Pharms, Lupin, Norvium Bioscience, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from thirty-one 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. Thirty-two 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. Thirty-two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 204058
| Tradename: | LISINOPRIL AND HYDROCHLOROTHIAZIDE |
| Applicant: | Invagen Pharms |
| Ingredient: | hydrochlorothiazide; lisinopril |
| Patents: | 0 |
Pharmacology for NDA: 204058
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 204058
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; lisinopril | TABLET;ORAL | 204058 | ANDA | A-S Medication Solutions | 50090-6094 | 50090-6094-0 | 30 TABLET in 1 BOTTLE (50090-6094-0) |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; lisinopril | TABLET;ORAL | 204058 | ANDA | A-S Medication Solutions | 50090-6094 | 50090-6094-1 | 90 TABLET in 1 BOTTLE (50090-6094-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;10MG | ||||
| Approval Date: | May 23, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
| Approval Date: | May 23, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;20MG | ||||
| Approval Date: | May 23, 2017 | TE: | AB | RLD: | No | ||||
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