Details for New Drug Application (NDA): 200045
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The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.
Summary for 200045
Tradename: | AMTURNIDE |
Applicant: | Novartis |
Ingredient: | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE;EQ 5MG BASE;12.5MG | ||||
Approval Date: | Dec 21, 2010 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE;EQ 5MG BASE;12.5MG | ||||
Approval Date: | Dec 21, 2010 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE;EQ 5MG BASE;25MG | ||||
Approval Date: | Dec 21, 2010 | TE: | RLD: | No |
Expired US Patents for NDA 200045
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-003 | Dec 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-001 | Dec 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
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