Details for New Drug Application (NDA): 210718
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NDA 210718 describes OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Hetero Labs Ltd V, Macleods Pharms Ltd, Ph Health, Piramal, Teva Pharms Usa, and Torrent, and is included in six NDAs. It is available from six suppliers. Additional details are available on the OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
The generic ingredient in OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 210718
| Tradename: | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Piramal |
| Ingredient: | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 210718
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 210718
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 210718 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-014 | 70436-014-04 | 30 TABLET, FILM COATED in 1 BOTTLE (70436-014-04) |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 210718 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-014 | 70436-014-06 | 90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;12.5MG;20MG | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;12.5MG;40MG | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;25MG;40MG | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
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