Details for New Drug Application (NDA): 202556
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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 202556
Tradename: | HYDROCHLOROTHIAZIDE |
Applicant: | Accord Hlthcare |
Ingredient: | hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 202556
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 202556
Suppliers and Packaging for NDA: 202556
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 202556 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7974 | 0615-7974-39 | 30 TABLET in 1 BLISTER PACK (0615-7974-39) |
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 202556 | ANDA | Accord Healthcare Inc. | 16729-182 | 16729-182-01 | 100 TABLET in 1 BOTTLE (16729-182-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No |
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