Details for New Drug Application (NDA): 205499
✉ Email this page to a colleague
NDA 205499 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 205499
| Tradename: | OLMESARTAN MEDOXOMIL |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 205499
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 205499
Suppliers and Packaging for NDA: 205499
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 205499 | ANDA | Camber Pharmaceuticals, Inc. | 31722-852 | 31722-852-30 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-852-30) |
| OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 205499 | ANDA | Camber Pharmaceuticals, Inc. | 31722-852 | 31722-852-90 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-852-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 31, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Oct 31, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Oct 31, 2024 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
