Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016834
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/06/1970 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/27/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/20/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/11/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/23/1976 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/24/1974 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |