Details for New Drug Application (NDA): 207437
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NDA 207437 describes OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Hetero Labs Ltd V, Macleods Pharms Ltd, Micro Labs, Ph Health, Piramal, Teva Pharms Usa, and Torrent, and is included in seven NDAs. It is available from eight 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 207437
| Tradename: | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Micro Labs |
| Ingredient: | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 207437
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 207437
| 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 | 207437 | ANDA | Micro Labs Limited | 42571-245 | 42571-245-05 | 500 TABLET, FILM COATED in 1 BOTTLE (42571-245-05) |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 207437 | ANDA | Micro Labs Limited | 42571-245 | 42571-245-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (42571-245-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;12.5MG;20MG | ||||
| Approval Date: | Nov 24, 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: | Nov 24, 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: | Nov 24, 2025 | TE: | AB | RLD: | No | ||||
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