Details for New Drug Application (NDA): 021990
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NDA 021990 describes EXFORGE, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the EXFORGE profile page.
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.
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 | 021990-004 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| 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 | 021990-005 | 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 |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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