Details for New Drug Application (NDA): 040807
✉ Email this page to a colleague
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 040807
Tradename: | HYDROCHLOROTHIAZIDE |
Applicant: | Ipca Labs Ltd |
Ingredient: | hydrochlorothiazide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040807
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 040807
Suppliers and Packaging for NDA: 040807
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 040807 | ANDA | Proficient Rx LP | 63187-074 | 63187-074-30 | 30 TABLET in 1 BOTTLE (63187-074-30) |
HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 040807 | ANDA | Proficient Rx LP | 63187-074 | 63187-074-90 | 90 TABLET in 1 BOTTLE (63187-074-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Jul 20, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 20, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 20, 2007 | TE: | AB | RLD: | No |
Complete Access Available with Subscription