Details for New Drug Application (NDA): 214489
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NDA 214489 describes AZILSARTAN MEDOXOMIL, which is a drug marketed by Lupin and Alkem Labs Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the AZILSARTAN MEDOXOMIL profile page.
The generic ingredient in AZILSARTAN MEDOXOMIL 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 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 214489
| Tradename: | AZILSARTAN MEDOXOMIL |
| Applicant: | Lupin |
| Ingredient: | azilsartan kamedoxomil |
| Patents: | 0 |
Pharmacology for NDA: 214489
| Mechanism of Action | Angiotensin 2 Type 1 Receptor Antagonists |
| Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 214489
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZILSARTAN MEDOXOMIL | azilsartan kamedoxomil | TABLET;ORAL | 214489 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-236 | 70748-236-06 | 30 TABLET in 1 BOTTLE (70748-236-06) |
| AZILSARTAN MEDOXOMIL | azilsartan kamedoxomil | TABLET;ORAL | 214489 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-237 | 70748-237-06 | 30 TABLET in 1 BOTTLE (70748-237-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG MEDOXOMIL | ||||
| Approval Date: | Jul 20, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 80MG MEDOXOMIL | ||||
| Approval Date: | Jul 20, 2022 | TE: | AB | RLD: | No | ||||
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