Details for New Drug Application (NDA): 021990
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The generic ingredient in EXFORGE 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 021990
Tradename: | EXFORGE |
Applicant: | Novartis |
Ingredient: | amlodipine besylate; valsartan |
Patents: | 0 |
Suppliers and Packaging for NDA: 021990
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990 | NDA | Novartis Pharmaceuticals Corporation | 0078-0488 | 0078-0488-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15) |
EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990 | NDA | Novartis Pharmaceuticals Corporation | 0078-0489 | 0078-0489-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0489-15) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;160MG | ||||
Approval Date: | Jun 20, 2007 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;160MG | ||||
Approval Date: | Jun 20, 2007 | TE: | AB | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;320MG | ||||
Approval Date: | Jun 20, 2007 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021990
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
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