Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008922
Company: BAUSCH
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VERSENATE | EDETATE CALCIUM DISODIUM | 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |