Details for New Drug Application (NDA): 040901
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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 040901
Tradename: | HYDRALAZINE HYDROCHLORIDE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | hydralazine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 040901
Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 040901
Suppliers and Packaging for NDA: 040901
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 040901 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7973 | 0615-7973-05 | 15 TABLET in 1 BLISTER PACK (0615-7973-05) |
HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 040901 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7973 | 0615-7973-39 | 30 TABLET in 1 BLISTER PACK (0615-7973-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 12, 2008 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 12, 2008 | TE: | AA | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 12, 2008 | TE: | AA | RLD: | No |
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