Details for New Drug Application (NDA): 201087
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NDA 201087 describes AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo Pharma, Lupin Ltd, Strides Pharma, Teva Pharms, and Torrent, and is included in five NDAs. It is available from three 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 201087
| Tradename: | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Applicant: | Strides Pharma |
| Ingredient: | amlodipine besylate; hydrochlorothiazide; valsartan |
| Patents: | 0 |
Pharmacology for NDA: 201087
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 201087
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 201087 | ANDA | Golden State Medical Supply, Inc. | 51407-668 | 51407-668-30 | 30 TABLET, FILM COATED in 1 BOTTLE (51407-668-30) |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 201087 | ANDA | Golden State Medical Supply, Inc. | 51407-669 | 51407-669-30 | 30 TABLET, FILM COATED in 1 BOTTLE (51407-669-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;12.5MG;160MG | ||||
| Approval Date: | Jun 1, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;25MG;160MG | ||||
| Approval Date: | Jun 1, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;12.5MG;160MG | ||||
| Approval Date: | Jun 1, 2015 | TE: | AB | RLD: | No | ||||
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