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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018421
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CITRATE LITHIUM CITRATE EQ 300MG CARBONATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP;ORAL Discontinued None Yes No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
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
10/13/2022 SUPPL-35 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-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
10/13/2022 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf
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
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