Details for New Drug Application (NDA): 206665
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NDA 206665 describes ALISKIREN HEMIFUMARATE, which is a drug marketed by Ph Health and is included in one NDA. It is available from one supplier. Additional details are available on the ALISKIREN HEMIFUMARATE profile page.
The generic ingredient in ALISKIREN HEMIFUMARATE is aliskiren hemifumarate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate profile page.
The generic ingredient in ALISKIREN HEMIFUMARATE is aliskiren hemifumarate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate profile page.
Summary for 206665
| Tradename: | ALISKIREN HEMIFUMARATE |
| Applicant: | Ph Health |
| 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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