Details for New Drug Application (NDA): 204734
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NDA 204734 describes FOSRENOL, which is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FOSRENOL profile page.
The generic ingredient in FOSRENOL is lanthanum carbonate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
The generic ingredient in FOSRENOL is lanthanum carbonate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
Summary for 204734
| Tradename: | FOSRENOL |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | lanthanum carbonate |
| Patents: | 2 |
Pharmacology for NDA: 204734
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 204734
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-256 | 54092-256-02 | 9 CARTON in 1 PACKAGE (54092-256-02) / 10 POWDER in 1 CARTON (54092-256-01) |
| FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-257 | 54092-257-02 | 9 CARTON in 1 CARTON (54092-257-02) / 10 POWDER in 1 CARTON (54092-257-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 750MG BASE | ||||
| Approval Date: | Sep 24, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 1, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 1, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 1GM BASE | ||||
| Approval Date: | Sep 24, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 1, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 204734
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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