Details for New Drug Application (NDA): 217490
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NDA 217490 describes AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE, which is a drug marketed by Alkem Labs Ltd and is included in one NDA. Additional details are available on the AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE profile page.
The generic ingredient in AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.
The generic ingredient in AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.
Summary for 217490
| Tradename: | AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | azilsartan kamedoxomil; chlorthalidone |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG MEDOXOMIL;12.5MG | ||||
| Approval Date: | Jan 21, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG MEDOXOMIL;25MG | ||||
| Approval Date: | Jan 21, 2025 | TE: | AB | RLD: | No | ||||
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