Details for New Drug Application (NDA): 090528
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The generic ingredient in LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 090528
Tradename: | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
Applicant: | Torrent Pharms |
Ingredient: | hydrochlorothiazide; losartan potassium |
Patents: | 0 |
Pharmacology for NDA: 090528
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 090528
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 090528 | ANDA | Proficient Rx LP | 63187-398 | 63187-398-30 | 30 TABLET in 1 BOTTLE (63187-398-30) |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 090528 | ANDA | Proficient Rx LP | 63187-398 | 63187-398-60 | 60 TABLET in 1 BOTTLE (63187-398-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;50MG | ||||
Approval Date: | Oct 6, 2010 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
Approval Date: | Oct 6, 2010 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;100MG | ||||
Approval Date: | Apr 6, 2010 | TE: | RLD: | No |
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