Details for New Drug Application (NDA): 040780
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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 040780
Tradename: | HYDROCHLOROTHIAZIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | hydrochlorothiazide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040780
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 040780
Suppliers and Packaging for NDA: 040780
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 040780 | ANDA | Aurobindo Pharma Limited | 65862-133 | 65862-133-01 | 100 TABLET in 1 BOTTLE (65862-133-01) |
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 040780 | ANDA | Aurobindo Pharma Limited | 65862-133 | 65862-133-99 | 1000 TABLET in 1 BOTTLE (65862-133-99) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 20, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 20, 2007 | TE: | AB | RLD: | No |
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