Details for New Drug Application (NDA): 090428
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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 090428
Tradename: | LOSARTAN POTASSIUM |
Applicant: | Alembic Pharms Ltd |
Ingredient: | losartan potassium |
Patents: | 0 |
Pharmacology for NDA: 090428
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090428
Suppliers and Packaging for NDA: 090428
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 090428 | ANDA | Alembic Pharmaceuticals Limited | 46708-445 | 46708-445-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-445-30) |
LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 090428 | ANDA | Alembic Pharmaceuticals Limited | 46708-445 | 46708-445-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-445-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Oct 6, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Oct 6, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Oct 6, 2010 | TE: | AB | RLD: | No |
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