Details for New Drug Application (NDA): 209281
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NDA 209281 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 209281
| Tradename: | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | hydrochlorothiazide; olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 209281
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 209281
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 209281 | ANDA | Accord Healthcare Inc. | 16729-366 | 16729-366-15 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-366-15) |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 209281 | ANDA | Accord Healthcare Inc. | 16729-367 | 16729-367-15 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-367-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
| Approval Date: | Feb 7, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
| Approval Date: | Feb 7, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;40MG | ||||
| Approval Date: | Feb 7, 2019 | TE: | AB | RLD: | No | ||||
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