Application 008922

Type: NDA
Sponsor: MEDICIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCIUM DISODIUM VERSENATE	EDETATE CALCIUM DISODIUM	INJECTABLE;INJECTION	200MG/ML	Yes	Yes
002	CALCIUM DISODIUM VERSENATE	EDETATE CALCIUM DISODIUM	TABLET;ORAL	500MG	No	No

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
N008922-001	CALCIUM DISODIUM VERSENATE	EDETATE CALCIUM DISODIUM	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N008922-002	CALCIUM DISODIUM VERSENATE	EDETATE CALCIUM DISODIUM	500MG	TABLET / ORAL		Approved before 1982

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008922-001	CALCIUM DISODIUM VERSENATE	200MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008922-002	CALCIUM DISODIUM VERSENATE	500MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`

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
Edetate Calcium Disodium	EDETATE CALCIUM DISODIUM	Rising Pharma Holdings, Inc.	710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22	2025-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: EDETATE CALCIUM DISODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
99207-240	Calcium Disodium Versenate	EDETATE CALCIUM DISODIUM	Medicis Pharmaceutical Corp	NDA	Current
99207-240	Calcium Disodium Versenate	EDETATE CALCIUM DISODIUM	Bausch Health US, LLC	NDA	Current
99207-240	Calcium Disodium Versenate	EDETATE CALCIUM DISODIUM	Bausch Health US, LLC	NDA	Current
99207-240	Calcium Disodium Versenate	EDETATE CALCIUM DISODIUM	Bausch Health Us, LLC	NDA	Current
99207-240	Calcium Disodium Versenate	EDETATE CALCIUM DISODIUM	Bausch Health Us, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75653	SUPPL	2023-10-03
75641	SUPPL	2023-10-03
73694	SUPPL	2023-03-07
73657	SUPPL	2023-03-03
32980	SUPPL	2009-06-05
172	SUPPL	2009-05-26