Details for New Drug Application (NDA): 201682
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NDA 201682 describes LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Rx, Granules, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from twenty-seven 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. Twenty-eight 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 201682
| Tradename: | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Applicant: | Ipca Labs Ltd |
| Ingredient: | hydrochlorothiazide; losartan potassium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;50MG | ||||
| Approval Date: | Mar 1, 2013 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;100MG | ||||
| Approval Date: | Mar 1, 2013 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Mar 1, 2013 | TE: | RLD: | No | |||||
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