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. |
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09/11/2020 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/11/2020 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/11/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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05/03/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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08/13/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |