Application 206868

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206868-001	LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24
A206868-002	LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24
A206868-003	LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206868-001	AB
A206868-002	AB
A206868-003	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 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206868-002	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206868-003	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206868-001	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	2022-01-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206868-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206868-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206868-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206868-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206868-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206868-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206868-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206868-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206868-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206868-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206868-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206868-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206868-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206868-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206868-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206868-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206868-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206868-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206868-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206868-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206868-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206868-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206868-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206868-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206868-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206868-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206868-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206868-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206868-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206868-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206868-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206868-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206868-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206868-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206868-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206868-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206868-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206868-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206868-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206868-001	AB	1	`1e350fbaab3a…`

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	Cipla USA Inc.	1d5ff930-1189-4e96-bdfb-9fd9c2c83d1b	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206868 application number: ANDA206868 ndc (product): 69097-936 ndc (product): 69097-935 ndc (product): 69097-934
Lanthanum carbonate	LANTHANUM CARBONATE	Exelan Pharmaceuticals, Inc.	16b0e6f5-4fc9-448c-994a-cb9dd8b03654	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206868 application number: ANDA206868 ndc (product): 76282-477 ndc (product): 76282-478 ndc (product): 76282-476

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-934	Lanthanum carbonate	LANTHANUM CARBONATE	Cipla USA Inc.	ANDA	Current
69097-934	Lanthanum carbonate	LANTHANUM CARBONATE	Cipla USA Inc.	ANDA	Current
69097-935	Lanthanum carbonate	LANTHANUM CARBONATE	Cipla USA Inc.	ANDA	Current
69097-935	Lanthanum carbonate	LANTHANUM CARBONATE	Cipla USA Inc.	ANDA	Current
69097-936	Lanthanum carbonate	LANTHANUM CARBONATE	Cipla USA Inc.	ANDA	Current
69097-936	Lanthanum carbonate	LANTHANUM CARBONATE	Cipla USA Inc.	ANDA	Current
76282-476	Lanthanum carbonate	LANTHANUM CARBONATE	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-476	Lanthanum carbonate	LANTHANUM CARBONATE	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-477	Lanthanum carbonate	LANTHANUM CARBONATE	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-477	Lanthanum carbonate	LANTHANUM CARBONATE	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-478	Lanthanum carbonate	LANTHANUM CARBONATE	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-478	Lanthanum carbonate	LANTHANUM CARBONATE	Exelan Pharmaceuticals, Inc.	ANDA	Current