Details for New Drug Application (NDA): 202713
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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 202713
Tradename: | AMLODIPINE BESYLATE AND VALSARTAN |
Applicant: | Alembic |
Ingredient: | amlodipine besylate; valsartan |
Patents: | 0 |
Suppliers and Packaging for NDA: 202713
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 202713 | ANDA | Alembic Pharmaceuticals Limited | 46708-458 | 46708-458-10 | 100 TABLET, FILM COATED in 1 CARTON (46708-458-10) |
AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 202713 | ANDA | Alembic Pharmaceuticals Limited | 46708-458 | 46708-458-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-458-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;160MG | ||||
Approval Date: | Apr 3, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;160MG | ||||
Approval Date: | Apr 3, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;320MG | ||||
Approval Date: | Apr 3, 2015 | TE: | AB | RLD: | No |
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