Details for New Drug Application (NDA): 040136
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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 040136
Tradename: | HYDRALAZINE HYDROCHLORIDE |
Applicant: | Am Regent |
Ingredient: | hydralazine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 040136
Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 040136
Suppliers and Packaging for NDA: 040136
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | INJECTABLE;INJECTION | 040136 | ANDA | American Regent, Inc. | 0517-0901 | 0517-0901-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25) / 1 mL in 1 VIAL, SINGLE-DOSE |
HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | INJECTABLE;INJECTION | 040136 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1648 | 51662-1648-3 | 25 POUCH in 1 CASE (51662-1648-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1648-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
Approval Date: | Jun 30, 1997 | TE: | AP | RLD: | No |
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