Details for New Drug Application (NDA): 209199
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NDA 209199 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, MSN, Natco Pharma Usa, Prinston Inc, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in fourteen NDAs. It is available from fourteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 209199
| Tradename: | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | hydrochlorothiazide; olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 209199
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 209199
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 209199 | ANDA | Camber Pharmaceuticals, Inc. | 31722-886 | 31722-886-30 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-886-30) |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 209199 | ANDA | Camber Pharmaceuticals, Inc. | 31722-886 | 31722-886-32 | 10 BLISTER PACK in 1 CARTON (31722-886-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
| Approval Date: | Jul 25, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
| Approval Date: | Jul 25, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;40MG | ||||
| Approval Date: | Jul 25, 2025 | TE: | AB | RLD: | No | ||||
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