Details for New Drug Application (NDA): 207804
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NDA 207804 describes OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Accord Hlthcare, Alembic, Aurobindo Pharma, Macleods Pharms Ltd, Natco Pharma Usa, Prinston Inc, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
The generic ingredient in OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 207804
| Tradename: | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
| Applicant: | Prinston Inc |
| Ingredient: | hydrochlorothiazide; olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 207804
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 207804
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 207804 | ANDA | Solco Healthcare US, LLC | 43547-391 | 43547-391-03 | 30 TABLET in 1 BOTTLE (43547-391-03) |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 207804 | ANDA | Solco Healthcare US, LLC | 43547-391 | 43547-391-09 | 90 TABLET in 1 BOTTLE (43547-391-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
| Approval Date: | Apr 24, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
| Approval Date: | Apr 24, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;40MG | ||||
| Approval Date: | Apr 24, 2017 | TE: | AB | RLD: | No | ||||
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