Details for New Drug Application (NDA): 204814
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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 204814
Tradename: | OLMESARTAN MEDOXOMIL |
Applicant: | Macleods Pharms Ltd |
Ingredient: | olmesartan medoxomil |
Patents: | 0 |
Pharmacology for NDA: 204814
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 204814
Suppliers and Packaging for NDA: 204814
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 204814 | ANDA | Macleods Pharmaceuticals Limited | 33342-178 | 33342-178-07 | 30 TABLET in 1 BOTTLE (33342-178-07) |
OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 204814 | ANDA | Macleods Pharmaceuticals Limited | 33342-178 | 33342-178-10 | 90 TABLET in 1 BOTTLE (33342-178-10) |
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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