Details for New Drug Application (NDA): 021468
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NDA 021468 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 four 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
Summary for 021468
| Tradename: | FOSRENOL |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | lanthanum carbonate |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021468
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 021468
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-252 | 54092-252-90 | 2 BOTTLE in 1 PACKAGE (54092-252-90) / 45 TABLET, CHEWABLE in 1 BOTTLE (54092-252-45) |
| FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-253 | 54092-253-90 | 6 BOTTLE in 1 PACKAGE (54092-253-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (54092-253-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Oct 26, 2004 | TE: | RLD: | No | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 26, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 26, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Oct 26, 2004 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 26, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE | ||||||||
Expired US Patents for NDA 021468
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-001 | Oct 26, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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