Details for New Drug Application (NDA): 020386
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The generic ingredient in COZAAR is losartan potassium. There are thirty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the losartan potassium profile page.
Summary for 020386
Tradename: | COZAAR |
Applicant: | Organon |
Ingredient: | losartan potassium |
Patents: | 0 |
Pharmacology for NDA: 020386
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 020386
Suppliers and Packaging for NDA: 020386
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COZAAR | losartan potassium | TABLET;ORAL | 020386 | NDA | Organon LLC | 78206-121 | 78206-121-01 | 90 TABLET, FILM COATED in 1 BOTTLE (78206-121-01) |
COZAAR | losartan potassium | TABLET;ORAL | 020386 | NDA | Organon LLC | 78206-122 | 78206-122-01 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-122-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Apr 14, 1995 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Apr 14, 1995 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Oct 13, 1998 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020386
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-002 | Apr 14, 1995 | 5,608,075*PED | ⤷ Subscribe |
Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-003 | Oct 13, 1998 | 5,608,075 | ⤷ Subscribe |
Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-001 | Apr 14, 1995 | 5,608,075*PED | ⤷ Subscribe |
Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-002 | Apr 14, 1995 | 5,608,075 | ⤷ Subscribe |
Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-001 | Apr 14, 1995 | 5,138,069*PED | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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