Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LITHIUM CITRATE | LITHIUM CITRATE | EQ 300MG CARBONATE/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
12/23/1980 | 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 |
---|---|---|---|---|---|
02/05/2020 | SUPPL-33 | 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-32 | 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 | |
06/12/2015 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/20/2011 | SUPPL-27 | 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-25 | 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 | |
11/08/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/31/2003 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17812slr023,18421slr021ltr.pdf |
08/06/1999 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/29/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/16/1997 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/16/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
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 |
11/26/2001 | SUPPL-15 | 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-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf |
11/26/1989 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf |
06/28/1988 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/26/1987 | 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. |
||
07/23/1984 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
03/24/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
01/31/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/29/1982 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/04/1981 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/05/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf | |
12/20/2018 | SUPPL-32 | 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-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf | |
10/20/2011 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf |
LITHIUM CITRATE
SYRUP;ORAL; EQ 300MG CARBONATE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LITHIUM CITRATE | LITHIUM CITRATE | EQ 300MG CARBONATE/5ML | SYRUP;ORAL | Prescription | Yes | AA | 018421 | HIKMA |
LITHIUM CITRATE | LITHIUM CITRATE | EQ 300MG CARBONATE/5ML | SYRUP;ORAL | Prescription | No | AA | 070755 | WOCKHARDT BIO AG |
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