Details for New Drug Application (NDA): 203110
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The generic ingredient in HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
Summary for 203110
Tradename: | HYDRALAZINE HYDROCHLORIDE |
Applicant: | Adrastea Pharma |
Ingredient: | hydralazine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203110
Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 203110
Suppliers and Packaging for NDA: 203110
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | INJECTABLE;INJECTION | 203110 | ANDA | Medical Purchasing Solutions, LLC | 71872-7050 | 71872-7050-1 | 1 VIAL in 1 BAG (71872-7050-1) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
Approval Date: | Jun 29, 2015 | TE: | AP | RLD: | No |
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