Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076366
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | LITHIUM CARBONATE | 450MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 08/21/2003 | 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 |
|---|---|---|---|---|---|
| 10/13/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/07/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/20/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |