Details for New Drug Application (NDA): 208465
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NDA 208465 describes OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Hangzhou Binjiang, Hetero Labs Ltd V, Macleods Pharms Ltd, Micro Labs, MSN, Natco Pharma Usa, Prinston Inc, Sciegen Pharms, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in sixteen NDAs. It is available from fifteen 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 208465
| Tradename: | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
| Applicant: | Sciegen Pharms |
| Ingredient: | hydrochlorothiazide; olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 208465
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 208465
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 208465 | ANDA | ScieGen Pharmaceuticals Inc | 50228-342 | 50228-342-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-342-10) |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 208465 | ANDA | ScieGen Pharmaceuticals Inc | 50228-342 | 50228-342-30 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-342-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
| Approval Date: | Mar 31, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
| Approval Date: | Mar 31, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;40MG | ||||
| Approval Date: | Mar 31, 2026 | TE: | AB | RLD: | No | ||||
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