Details for New Drug Application (NDA): 208659
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NDA 208659 describes OLMESARTAN MEDOXOMIL, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Inventia, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Prinston Inc, Qilu, Rising, Sandoz, Sciegen Pharms Inc, Sunshine, Teva Pharms Usa, Torrent, Umedica, Zydus Pharms, Hangzhou Binjiang, Natco Pharma Usa, Ph Health, and Piramal, and is included in forty-five NDAs. It is available from twenty-nine suppliers. Additional details are available on the OLMESARTAN MEDOXOMIL profile page.
The generic ingredient in OLMESARTAN MEDOXOMIL is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Seven 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 is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 208659
| Tradename: | OLMESARTAN MEDOXOMIL |
| Applicant: | Inventia |
| Ingredient: | olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 208659
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 208659
Suppliers and Packaging for NDA: 208659
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 208659 | ANDA | Inventia Healthcare Limited | 49252-065 | 49252-065-10 | 30 TABLET, COATED in 1 BOTTLE (49252-065-10) |
| OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 208659 | ANDA | Inventia Healthcare Limited | 49252-065 | 49252-065-12 | 90 TABLET, COATED in 1 BOTTLE (49252-065-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 18, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | May 18, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | May 18, 2020 | TE: | AB | RLD: | No | ||||
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