Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070755
Company: PAI HOLDINGS PHARM
Company: PAI HOLDINGS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LITHIUM CITRATE | LITHIUM CITRATE | EQ 300MG CARBONATE/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 05/21/1986 | 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-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/13/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/28/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/22/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/05/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/12/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/29/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/27/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/25/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/17/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 11/10/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |