Details for New Drug Application (NDA): 090510
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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 090510
Tradename: | HYDROCHLOROTHIAZIDE |
Applicant: | Unichem |
Ingredient: | hydrochlorothiazide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090510
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 090510
Suppliers and Packaging for NDA: 090510
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | CAPSULE;ORAL | 090510 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-130 | 29300-130-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (29300-130-01) |
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | CAPSULE;ORAL | 090510 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-130 | 29300-130-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (29300-130-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 12.5MG | ||||
Approval Date: | Jan 19, 2010 | TE: | AB | RLD: | No |
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