Details for New Drug Application (NDA): 022026
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The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 022026
Tradename: | AMLODIPINE BESYLATE |
Applicant: | Synthon Pharms |
Ingredient: | amlodipine besylate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Sep 27, 2007 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Sep 27, 2007 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Sep 27, 2007 | TE: | RLD: | Yes |
Expired US Patents for NDA 022026
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Synthon Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET, ORALLY DISINTEGRATING;ORAL | 022026-001 | Sep 27, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Synthon Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET, ORALLY DISINTEGRATING;ORAL | 022026-003 | Sep 27, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Synthon Pharms | AMLODIPINE BESYLATE | amlodipine besylate | TABLET, ORALLY DISINTEGRATING;ORAL | 022026-002 | Sep 27, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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