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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008922
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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VERSENATE EDETATE CALCIUM DISODIUM 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
CALCIUM DISODIUM VERSENATE EDETATE CALCIUM DISODIUM 500MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/1953 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2023 SUPPL-22 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008922s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/008922Orig1s022ltr.pdf
06/17/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/21/2013 SUPPL-18 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008922Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/008922Orig1s018ltr.pdf
05/19/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008922s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/008922s016ltr.pdf
04/12/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/26/1996 SUPPL-14 Labeling

Label is not available on this site.

10/05/1992 SUPPL-13 Labeling

Label is not available on this site.

03/03/1992 SUPPL-12 Labeling

Label is not available on this site.

04/25/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/29/2023 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008922s022lbl.pdf
09/29/2023 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008922s022lbl.pdf
06/21/2013 SUPPL-18 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008922Orig1s018lbl.pdf
05/19/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008922s016lbl.pdf
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