Details for New Drug Application (NDA): 204901
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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 204901
Tradename: | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
Applicant: | Prinston Inc |
Ingredient: | hydrochlorothiazide; losartan potassium |
Patents: | 0 |
Pharmacology for NDA: 204901
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 204901
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 204901 | ANDA | Solco Healthcare US, LLC | 43547-423 | 43547-423-03 | 30 TABLET, FILM COATED in 1 BOTTLE (43547-423-03) |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 204901 | ANDA | Solco Healthcare US, LLC | 43547-423 | 43547-423-09 | 90 TABLET, FILM COATED in 1 BOTTLE (43547-423-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;50MG | ||||
Approval Date: | Nov 6, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;100MG | ||||
Approval Date: | Nov 6, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
Approval Date: | Nov 6, 2017 | TE: | AB | RLD: | No |
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