Details for New Drug Application (NDA): 201845
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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 201845
Tradename: | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
Applicant: | Jubilant Cadista |
Ingredient: | hydrochlorothiazide; losartan potassium |
Patents: | 0 |
Pharmacology for NDA: 201845
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 201845
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 201845 | ANDA | AvKARE | 42291-502 | 42291-502-90 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-502-90) |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 201845 | ANDA | AvKARE | 42291-503 | 42291-503-90 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-503-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;50MG | ||||
Approval Date: | Sep 18, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;100MG | ||||
Approval Date: | Sep 18, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
Approval Date: | Sep 18, 2012 | TE: | AB | RLD: | No |
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