Application 204734

Type: NDA
Sponsor: SHIRE DEV LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSRENOL	LANTHANUM CARBONATE	POWDER;ORAL	EQ 750MG BASE	Yes	No
002	FOSRENOL	LANTHANUM CARBONATE	POWDER;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204734-001	FOSRENOL	LANTHANUM CARBONATE	EQ 750MG BASE	POWDER / ORAL		RLD	2014-09-24
N204734-002	FOSRENOL	LANTHANUM CARBONATE	EQ 1GM BASE	POWDER / ORAL		RLD, RS	2014-09-24

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N204734-001	8980327	2030-12-01	Drug product	2015-04-02
N204734-001	9023397	2030-12-01	Drug product	2015-12-16
N204734-002	8980327	2030-12-01	Drug product	2015-04-02
N204734-002	9023397	2030-12-01	Drug product	2015-12-16

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204734-001	FOSRENOL	EQ 750MG BASE	POWDER / ORAL	RLD	2014-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204734-002	FOSRENOL	EQ 1GM BASE	POWDER / ORAL	RLD, RS	2014-09-24	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204734-001	9023397	2030-12-01	Drug product	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204734-002	8980327	2030-12-01	Drug product	2015-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204734-002	9023397	2030-12-01	Drug product	2015-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204734-001	9023397	2030-12-01	Drug product	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204734-002	8980327	2030-12-01	Drug product	2015-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204734-002	9023397	2030-12-01	Drug product	2015-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204734-001	9023397	2030-12-01	Drug product	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204734-002	8980327	2030-12-01	Drug product	2015-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204734-002	9023397	2030-12-01	Drug product	2015-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204734-001	9023397	2030-12-01	Drug product	2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204734-002	8980327	2030-12-01	Drug product	2015-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204734-002	9023397	2030-12-01	Drug product	2015-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204734-001	9023397	2030-12-01	Drug product	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204734-002	8980327	2030-12-01	Drug product	2015-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204734-002	9023397	2030-12-01	Drug product	2015-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204734-001	7465465	2024-08-26	Drug product	2014-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204734-001	9023397	2030-12-01	Drug product	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204734-002	7465465	2024-08-26	Drug product	2014-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204734-002	8980327	2030-12-01	Drug product	2015-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204734-002	9023397	2030-12-01	Drug product	2015-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204734-001	7465465	2024-08-26	Drug product	2014-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204734-001	9023397	2030-12-01	Drug product	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204734-002	7465465	2024-08-26	Drug product	2014-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204734-002	8980327	2030-12-01	Drug product	2015-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204734-002	9023397	2030-12-01	Drug product	2015-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204734-001	7465465	2024-08-26	Drug product	2014-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204734-001	9023397	2030-12-01	Drug product	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204734-002	7465465	2024-08-26	Drug product	2014-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204734-002	8980327	2030-12-01	Drug product	2015-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204734-002	9023397	2030-12-01	Drug product	2015-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204734-001	7465465	2024-08-26	Drug product	2014-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204734-001	8980327	2030-12-01	Drug product	2015-04-02	`d8e5a09893c0…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosrenol	LANTHANUM CARBONATE	Takeda Pharmaceuticals America, Inc.	f10776b2-2c25-4343-aabe-68f302e5cb54	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204734 application number: NDA204734 ndc (product): 54092-257 ndc (product): 54092-256

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-256	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-256	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-256	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-256	Fosrenol	lanthanum carbonate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-257	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-257	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-257	Fosrenol	lanthanum carbonate	Shire US Manufacturing Inc.	NDA	Current
54092-257	Fosrenol	lanthanum carbonate	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79527	SUPPL	2024-09-03
79515	SUPPL	2024-09-02
79514	SUPPL	2024-09-02
76789	SUPPL	2023-12-13
76782	SUPPL	2023-12-13
74225	SUPPL	2023-05-11
74222	SUPPL	2023-05-11
62915	SUPPL	2020-05-12
62914	SUPPL	2020-05-12
62911	SUPPL	2020-05-12
56676	SUPPL	2018-12-07
56414	SUPPL	2018-11-12
56413	SUPPL	2018-11-12
44982	SUPPL	2016-02-24
44981	SUPPL	2016-02-24
44985	ORIG	2014-09-24
44984	ORIG	2014-09-24
44980	ORIG	2014-09-24
44979	ORIG	2014-09-24