Details for New Drug Application (NDA): 088358
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NDA 088358 describes HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50, which is a drug marketed by Ivax Pharms and is included in one NDA. Additional details are available on the HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 profile page.
The generic ingredient in HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 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 HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 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 088358
| Tradename: | HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 |
| Applicant: | Ivax Pharms |
| Ingredient: | hydralazine hydrochloride; hydrochlorothiazide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG;50MG | ||||
| Approval Date: | Apr 10, 1984 | TE: | RLD: | No | |||||
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