Details for New Drug Application (NDA): 091541
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The generic ingredient in LOSARTAN POTASSIUM 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 091541
Tradename: | LOSARTAN POTASSIUM |
Applicant: | Micro Labs |
Ingredient: | losartan potassium |
Patents: | 0 |
Pharmacology for NDA: 091541
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 091541
Suppliers and Packaging for NDA: 091541
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 091541 | ANDA | Micro Labs Limited | 42571-110 | 42571-110-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (42571-110-10) |
LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 091541 | ANDA | Micro Labs Limited | 42571-110 | 42571-110-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42571-110-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No |
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