Details for New Drug Application (NDA): 204801
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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 204801
Tradename: | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | hydrochlorothiazide; olmesartan medoxomil |
Patents: | 0 |
Pharmacology for NDA: 204801
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 204801
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 204801 | ANDA | Macleods Pharmaceuticals Limited | 33342-173 | 33342-173-07 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-173-07) |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 204801 | ANDA | Macleods Pharmaceuticals Limited | 33342-173 | 33342-173-10 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-173-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
Approval Date: | Jun 1, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
Approval Date: | Jun 1, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;40MG | ||||
Approval Date: | Jun 1, 2023 | TE: | AB | RLD: | No |
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