Details for New Drug Application (NDA): 090011
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The generic ingredient in AMLODIPINE BESYLATE AND VALSARTAN is amlodipine besylate; valsartan. There are fifty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.
Summary for 090011
Tradename: | AMLODIPINE BESYLATE AND VALSARTAN |
Applicant: | Strides Pharma |
Ingredient: | amlodipine besylate; valsartan |
Patents: | 0 |
Suppliers and Packaging for NDA: 090011
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090011 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-844 | 23155-844-03 | 30 TABLET in 1 BOTTLE, PLASTIC (23155-844-03) |
AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090011 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-844 | 23155-844-09 | 90 TABLET in 1 BOTTLE, PLASTIC (23155-844-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;160MG | ||||
Approval Date: | Mar 28, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;160MG | ||||
Approval Date: | Mar 28, 2013 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;320MG | ||||
Approval Date: | Mar 28, 2013 | TE: | AB | RLD: | No |
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