Details for New Drug Application (NDA): 203561
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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 203561
Tradename: | HYDROCHLOROTHIAZIDE |
Applicant: | Sciegen Pharms Inc |
Ingredient: | hydrochlorothiazide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203561
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 203561
Suppliers and Packaging for NDA: 203561
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | CAPSULE;ORAL | 203561 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8344 | 0615-8344-05 | 15 CAPSULE in 1 BLISTER PACK (0615-8344-05) |
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | CAPSULE;ORAL | 203561 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8344 | 0615-8344-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8344-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 12.5MG | ||||
Approval Date: | Jan 14, 2019 | TE: | AB | RLD: | No |
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