Details for New Drug Application (NDA): 078164
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The generic ingredient in HYDROCHLOROTHIAZIDE 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 078164
Tradename: | HYDROCHLOROTHIAZIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | hydrochlorothiazide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078164
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 078164
Suppliers and Packaging for NDA: 078164
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | CAPSULE;ORAL | 078164 | ANDA | A-S Medication Solutions | 50090-5672 | 50090-5672-0 | 30 CAPSULE in 1 BOTTLE (50090-5672-0) |
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | CAPSULE;ORAL | 078164 | ANDA | A-S Medication Solutions | 50090-5672 | 50090-5672-1 | 100 CAPSULE in 1 BOTTLE (50090-5672-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 12.5MG | ||||
Approval Date: | Sep 18, 2007 | TE: | AB | RLD: | No |
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