Details for New Drug Application (NDA): 091648
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NDA 091648 describes TELMISARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin, Macleods Pharms, Mankind Pharma, Natco, Prinston Inc, Torrent, and Zydus Pharms, and is included in ten NDAs. It is available from seven suppliers. Additional details are available on the TELMISARTAN AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 091648
| Tradename: | TELMISARTAN AND HYDROCHLOROTHIAZIDE |
| Applicant: | Natco |
| Ingredient: | hydrochlorothiazide; telmisartan |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
| Approval Date: | Feb 25, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG;80MG | ||||
| Approval Date: | Feb 25, 2014 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;80MG | ||||
| Approval Date: | Feb 25, 2014 | TE: | RLD: | No | |||||
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