Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076243
Company: MYLAN
Company: MYLAN
| 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 |
| LITHIUM CARBONATE | LITHIUM CARBONATE | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/27/2002 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076243_S000_LithiumTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2018 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2016 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/06/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/24/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/24/2003 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |