Details for New Drug Application (NDA): 207037
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NDA 207037 describes HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL, which is a drug marketed by Alkem Labs Ltd and is included in one NDA. Additional details are available on the HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL profile page.
The generic ingredient in HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 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 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 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 207037
| Tradename: | HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | hydrochlorothiazide; olmesartan medoxomil |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;20MG | ||||
| Approval Date: | Jul 11, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
| Approval Date: | Jul 11, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;40MG | ||||
| Approval Date: | Jul 11, 2024 | TE: | AB | RLD: | No | ||||
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