Details for New Drug Application (NDA): 209028
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NDA 209028 describes TELMISARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Natco, Prinston Inc, Torrent, and Zydus Pharms, and is included in ten NDAs. It is available from six suppliers. Additional details are available on the TELMISARTAN AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Seven 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 are thirty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 209028
| Tradename: | TELMISARTAN AND HYDROCHLOROTHIAZIDE |
| Applicant: | Prinston Inc |
| Ingredient: | hydrochlorothiazide; telmisartan |
| Patents: | 0 |
Pharmacology for NDA: 209028
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 209028
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TELMISARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; telmisartan | TABLET;ORAL | 209028 | ANDA | Solco Healthcare LLC | 43547-441 | 43547-441-03 | 30 TABLET in 1 BOTTLE (43547-441-03) |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; telmisartan | TABLET;ORAL | 209028 | ANDA | Solco Healthcare LLC | 43547-441 | 43547-441-09 | 90 TABLET in 1 BOTTLE (43547-441-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
| Approval Date: | Nov 6, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;80MG | ||||
| Approval Date: | Nov 6, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;80MG | ||||
| Approval Date: | Nov 6, 2017 | TE: | AB | RLD: | No | ||||
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