Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076795
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 11/22/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/12/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2020 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2020 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/11/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/03/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |