Details for New Drug Application (NDA): 201593
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NDA 201593 describes AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo Pharma, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma, Teva Pharms, and Torrent, and is included in six NDAs. It is available from four suppliers. Additional details are available on the AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
The generic ingredient in AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 201593
| Tradename: | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Applicant: | Torrent |
| Ingredient: | amlodipine besylate; hydrochlorothiazide; valsartan |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;12.5MG;160MG | ||||
| Approval Date: | Jun 3, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;25MG;160MG | ||||
| Approval Date: | Jun 3, 2015 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;12.5MG;160MG | ||||
| Approval Date: | Jun 3, 2015 | TE: | RLD: | No | |||||
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