Details for New Drug Application (NDA): 077516
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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 077516
Tradename: | AMLODIPINE BESYLATE |
Applicant: | Strides Pharma |
Ingredient: | amlodipine besylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077516
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Suppliers and Packaging for NDA: 077516
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 077516 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8282 | 0615-8282-05 | 15 TABLET in 1 BLISTER PACK (0615-8282-05) |
AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 077516 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8282 | 0615-8282-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8282-30) / 5 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Jul 11, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jul 11, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jul 11, 2007 | TE: | AB | RLD: | No |
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