Details for New Drug Application (NDA): 078385
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NDA 078385 describes LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Granules, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Sandoz, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from thirty suppliers. Additional details are available on the LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE profile page.
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.
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 078385
| Tradename: | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | hydrochlorothiazide; losartan potassium |
| Patents: | 0 |
Pharmacology for NDA: 078385
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 078385
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 078385 | ANDA | Zydus Lifesciences Limited | 65841-732 | 65841-732-06 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-732-06) |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 078385 | ANDA | Zydus Lifesciences Limited | 65841-732 | 65841-732-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-732-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;50MG | ||||
| Approval Date: | Oct 6, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Oct 6, 2010 | TE: | AB | RLD: | No | ||||
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