Details for New Drug Application (NDA): 078243
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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 078243
Tradename: | LOSARTAN POTASSIUM |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | losartan potassium |
Patents: | 0 |
Pharmacology for NDA: 078243
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078243
Suppliers and Packaging for NDA: 078243
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 078243 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7958 | 0615-7958-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7958-05) |
LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 078243 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7958 | 0615-7958-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7958-39) |
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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