Drugs@FDA: FDA-Approved Drugs
Company: NOVEN THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESKALITH | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/1970 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 03/11/2004 | SUPPL-74 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16860slr074,18152slr020ltr.pdf | |
| 08/05/2002 | SUPPL-73 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860slr073,17971slr019,18152slr017ltr.pdf |
| 05/08/2002 | SUPPL-72 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf |
| 04/06/2000 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/2000 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-69 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf |
| 05/08/2002 | SUPPL-68 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf |
| 05/08/2002 | SUPPL-67 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf |
| 08/30/1994 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-65 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf |
| 11/30/1984 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-59 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf |
| 01/27/1983 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 11/18/1982 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1982 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 12/02/1981 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 09/11/1981 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 09/19/1980 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 04/16/1980 | SUPPL-50 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/06/1980 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 02/06/1980 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 09/27/1979 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 09/27/1979 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 04/24/1979 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 01/25/1978 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 10/04/1977 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/29/1975 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1975 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1975 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1975 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/17/1974 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/23/1974 | SUPPL-8 | Unspecified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/11/2004 | SUPPL-74 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf |