Details for New Drug Application (NDA): 008303
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NDA 008303 describes APRESOLINE, which is a drug marketed by Novartis and is included in two NDAs. Additional details are available on the APRESOLINE profile page.
The generic ingredient in APRESOLINE 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 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 008303
| Tradename: | APRESOLINE |
| Applicant: | Novartis |
| Ingredient: | hydralazine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 008303
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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