Details for New Drug Application (NDA): 206665
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The generic ingredient in ALISKIREN HEMIFUMARATE is aliskiren hemifumarate. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate profile page.
Summary for 206665
Tradename: | ALISKIREN HEMIFUMARATE |
Applicant: | Endo Operations |
Ingredient: | aliskiren hemifumarate |
Patents: | 0 |
Pharmacology for NDA: 206665
Mechanism of Action | Renin Inhibitors |
Suppliers and Packaging for NDA: 206665
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALISKIREN HEMIFUMARATE | aliskiren hemifumarate | TABLET;ORAL | 206665 | ANDA | Endo USA, Inc. | 49884-424 | 49884-424-11 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-424-11) |
ALISKIREN HEMIFUMARATE | aliskiren hemifumarate | TABLET;ORAL | 206665 | ANDA | Endo USA, Inc. | 49884-425 | 49884-425-11 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Mar 22, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | Mar 22, 2019 | TE: | AB | RLD: | No |
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