Details for New Drug Application (NDA): 203012
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NDA 203012 describes OLMESARTAN MEDOXOMIL, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Chartwell Rx, Glenmark Pharms Ltd, 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, Natco Pharma Usa, and Endo Operations, and is included in thirty-six NDAs. It is available from twenty-eight 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 203012
| Tradename: | OLMESARTAN MEDOXOMIL |
| Applicant: | Alembic |
| Ingredient: | olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 203012
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 203012
Suppliers and Packaging for NDA: 203012
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 203012 | ANDA | Alembic Pharmaceuticals Limited | 46708-131 | 46708-131-10 | 100 TABLET, FILM COATED in 1 CARTON (46708-131-10) |
| OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 203012 | ANDA | Alembic Pharmaceuticals Limited | 46708-131 | 46708-131-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-131-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 24, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Apr 24, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 24, 2017 | TE: | AB | RLD: | No | ||||
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