Home Applications 008922 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 44 .
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VERSENATE EDETATE CALCIUM DISODIUM 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 N008922-002 CALCIUM DISODIUM VERSENATE EDETATE CALCIUM DISODIUM 500MG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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N008922-001 CALCIUM DISODIUM VERSENATE 200MG/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N008922-002 CALCIUM DISODIUM VERSENATE 500MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N008922-001 CALCIUM DISODIUM VERSENATE 200MG/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N008922-002 CALCIUM DISODIUM VERSENATE 500MG TABLET / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N008922-001 CALCIUM DISODIUM VERSENATE 200MG/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N008922-002 CALCIUM DISODIUM VERSENATE 500MG TABLET / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 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 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N008922-002 CALCIUM DISODIUM VERSENATE 500MG TABLET / ORAL Approved before 1982 a50c72e98297…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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