Details for New Drug Application (NDA): 012026
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NDA 012026 describes APRESOLINE-ESIDRIX, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the APRESOLINE-ESIDRIX profile page.
The generic ingredient in APRESOLINE-ESIDRIX is hydralazine hydrochloride; hydrochlorothiazide. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide profile page.
The generic ingredient in APRESOLINE-ESIDRIX is hydralazine hydrochloride; hydrochlorothiazide. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide profile page.
Summary for 012026
| Tradename: | APRESOLINE-ESIDRIX |
| Applicant: | Novartis |
| Ingredient: | hydralazine hydrochloride; hydrochlorothiazide |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;15MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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