Application 021468

Type: NDA
Sponsor: SHIRE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSRENOL	LANTHANUM CARBONATE	TABLET, CHEWABLE;ORAL	EQ 250MG BASE	No	No
002	FOSRENOL	LANTHANUM CARBONATE	TABLET, CHEWABLE;ORAL	EQ 500MG BASE	Yes	No
003	FOSRENOL	LANTHANUM CARBONATE	TABLET, CHEWABLE;ORAL	EQ 750MG BASE	Yes	No
004	FOSRENOL	LANTHANUM CARBONATE	TABLET, CHEWABLE;ORAL	EQ 1GM BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021468-001	FOSRENOL	LANTHANUM CARBONATE	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26
N021468-002	FOSRENOL	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26
N021468-003	FOSRENOL	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23
N021468-004	FOSRENOL	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021468-002	AB
N021468-003	AB
N021468-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021468-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021468-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021468-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021468-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021468-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021468-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021468-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021468-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021468-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021468-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021468-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021468-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021468-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021468-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021468-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021468-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021468-002	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-001	7381428	2024-08-26	U-890		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-001	7465465	2024-08-26		Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-002	7381428	2024-08-26	U-890		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-002	7465465	2024-08-26		Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-003	7381428	2024-08-26	U-890		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-003	7465465	2024-08-26		Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-004	7381428	2024-08-26	U-890		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-004	7465465	2024-08-26		Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-001	7381428	2024-08-26	U-890		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-001	7465465	2024-08-26		Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-002	7381428	2024-08-26	U-890		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-002	7465465	2024-08-26		Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-003	7381428	2024-08-26	U-890		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-003	7465465	2024-08-26		Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-004	7381428	2024-08-26	U-890		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-004	7465465	2024-08-26		Drug product	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-001	7381428	2024-08-26	U-890		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-001	7465465	2024-08-26		Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-002	7381428	2024-08-26	U-890		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-002	7465465	2024-08-26		Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-003	7381428	2024-08-26	U-890		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-003	7465465	2024-08-26		Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-004	7381428	2024-08-26	U-890		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-004	7465465	2024-08-26		Drug product	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-001	7381428	2024-08-26	U-890		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-001	7465465	2024-08-26		Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-002	7381428	2024-08-26	U-890		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-002	7465465	2024-08-26		Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-003	7381428	2024-08-26	U-890		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-003	7465465	2024-08-26		Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-004	7381428	2024-08-26	U-890		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-004	7465465	2024-08-26		Drug product	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021468-001	7381428	2024-08-26	U-890		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-001	7465465	2024-08-26		Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-002	7381428	2024-08-26	U-890		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-002	7465465	2024-08-26		Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-003	7381428	2024-08-26	U-890		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-003	7465465	2024-08-26		Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-004	7381428	2024-08-26	U-890		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-004	7465465	2024-08-26		Drug product	`d06236e962d9…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	bb263fe8-2bdf-4dba-807f-194f54a73654	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021468 application number: NDA021468 ndc (product): 66993-424 ndc (product): 66993-422 ndc (product): 66993-423
Fosrenol	LANTHANUM CARBONATE	Takeda Pharmaceuticals America, Inc.	f10776b2-2c25-4343-aabe-68f302e5cb54	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021468 application number: NDA021468 ndc (product): 54092-253 ndc (product): 54092-254 ndc (product): 54092-252

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-252	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-252	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-252	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-252	Fosrenol	lanthanum carbonate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-253	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-253	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-253	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-253	Fosrenol	lanthanum carbonate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-254	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-254	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-254	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-254	Fosrenol	lanthanum carbonate	Takeda Pharmaceuticals America, Inc.	NDA	Current
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79530	SUPPL	2024-09-03
79516	SUPPL	2024-09-02
79509	SUPPL	2024-08-30
76788	SUPPL	2023-12-13
76781	SUPPL	2023-12-13
74224	SUPPL	2023-05-11
74218	SUPPL	2023-05-11
62913	SUPPL	2020-05-12
62912	SUPPL	2020-05-12
62910	SUPPL	2020-05-12
56675	SUPPL	2018-12-07
56412	SUPPL	2018-11-12
56411	SUPPL	2018-11-12
56356	SUPPL	2018-11-08
37012	SUPPL	2016-02-26
5462	SUPPL	2016-02-26
37011	SUPPL	2014-09-26
27874	SUPPL	2014-09-26
27873	SUPPL	2012-11-05
15541	SUPPL	2012-11-02
15540	SUPPL	2011-09-07
5461	SUPPL	2011-09-07
37010	SUPPL	2011-04-29
27872	SUPPL	2011-04-29
15539	SUPPL	2011-04-29
5460	SUPPL	2011-04-29
42183	SUPPL	2011-01-04
21675	SUPPL	2011-01-04
5459	SUPPL	2008-10-28
27871	SUPPL	2008-04-11
27870	SUPPL	2006-03-23
21674	ORIG	2005-01-28
15538	ORIG	2004-11-01
5458	ORIG	2004-10-29