Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
LITHIUM CARBONATE | LITHIUM CARBONATE | 150MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
LITHIUM CARBONATE | LITHIUM CARBONATE | 600MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
11/26/1980 | 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-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017812Orig1s036,018558Orig1s030,018421Orig1s035ltr.pdf | |
02/05/2020 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017812Orig1s034, 018421Orig1s033, 018558Orig1s028ltr.pdf | |
12/20/2018 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017812Orig1s033, 018421Orig1s032, 018558Orig1s027Ltr.pdf | |
10/04/2018 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017812Orig1s031,018421Orig1s031,018558Orig1s026ltr.pdf | |
02/26/2016 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/20/2011 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017812s028,018421s027ltr.pdf | |
10/25/2016 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf | |
10/05/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
01/31/2003 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17812slr023,18421slr021ltr.pdf |
11/21/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/14/2001 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17812s21ltr.pdf |
12/06/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/17/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/03/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/2001 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf |
11/26/2001 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf |
08/01/1994 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/26/2001 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf |
11/26/2001 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf |
02/10/1988 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/26/2001 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf |
09/29/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/28/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
01/28/1987 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
01/28/1987 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
06/14/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
01/31/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
01/06/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/09/1982 | 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-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf | |
02/05/2020 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf | |
12/20/2018 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf | |
10/04/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf | |
10/25/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf | |
10/20/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf |
LITHIUM CARBONATE
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 079159 | ALEMBIC LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | CAPSULE;ORAL | Prescription | No | AB | 079139 | GLENMARK PHARMS LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090702 | HETERO LABS LTD III |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 017812 | HIKMA |
CAPSULE;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LITHIUM CARBONATE | LITHIUM CARBONATE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 079159 | ALEMBIC LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 079139 | GLENMARK PHARMS LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 090702 | HETERO LABS LTD III |
LITHIUM CARBONATE | LITHIUM CARBONATE | 150MG | CAPSULE;ORAL | Prescription | Yes | AB | 017812 | HIKMA |
CAPSULE;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LITHIUM CARBONATE | LITHIUM CARBONATE | 600MG | CAPSULE;ORAL | Prescription | No | AB | 079159 | ALEMBIC LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 600MG | CAPSULE;ORAL | Prescription | No | AB | 079139 | GLENMARK PHARMS LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 600MG | CAPSULE;ORAL | Prescription | No | AB | 090702 | HETERO LABS LTD III |
LITHIUM CARBONATE | LITHIUM CARBONATE | 600MG | CAPSULE;ORAL | Prescription | Yes | AB | 017812 | HIKMA |