Details for New Drug Application (NDA): 021468
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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 |
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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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