Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018027
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LITHOBID | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/27/1979 | 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 |
|---|---|---|---|---|---|
| 10/13/2022 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018027s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018027Orig1s069ltr.pdf | |
| 02/05/2020 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018027s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018027Orig1s067ltr.pdf | |
| 12/20/2018 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018027Orig1s065Ltr.pdf | |
| 04/30/2018 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018027Orig1s064ltr.pdf | |
| 05/27/2016 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018027s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018027Orig1s059ltr.pdf | |
| 05/11/2015 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/2011 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018027s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018027s056ltr.pdf | |
| 10/01/2006 | SUPPL-55 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018027s055LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018027_s055_lithobid_LBL.pdf |
| 04/07/2006 | SUPPL-51 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018027s051ltr.pdf |
| 10/07/2002 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf | |
| 10/16/2001 | SUPPL-48 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/22/2000 | SUPPL-47 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/07/2002 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf | |
| 07/11/1997 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/1995 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/2002 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf | |
| 05/02/1990 | SUPPL-37 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/07/2002 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 04/20/1990 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 10/13/1988 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/13/1988 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/24/1988 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/07/2002 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/07/2002 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/01/1986 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1985 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1983 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/25/1983 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1982 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/25/1981 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/06/1981 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/1981 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/13/1980 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1979 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/03/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/04/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/03/1979 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/13/1979 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/13/2022 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018027s069lbl.pdf | |
| 02/05/2020 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018027s067lbl.pdf | |
| 12/20/2018 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s065lbl.pdf | |
| 04/30/2018 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s064lbl.pdf | |
| 05/27/2016 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018027s059lbl.pdf | |
| 10/20/2011 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018027s056lbl.pdf | |
| 10/07/2002 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf | |
| 10/07/2002 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf | |
| 10/07/2002 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf |
LITHOBID
TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091544 | GLENMARK PHARMS INC |
| LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205532 | HERITAGE PHARMA |
| LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076832 | HIKMA |
| LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202288 | MYLAN PHARMS INC |
| LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204779 | UNIQUE |
| LITHOBID | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 018027 | ANI PHARMS |