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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018558
Company: HIKMA

Medication Guide

Products on NDA 018558

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018558

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1982	ORIG-1	Approval				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-30	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
10/13/2022	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
02/05/2020	SUPPL-28	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-27	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-26	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
05/06/2016	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
12/06/2011	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
10/25/2016	SUPPL-21	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
10/31/2007	SUPPL-19	Labeling		Label is not available on this site.
02/10/2003	SUPPL-17	Labeling		Label is not available on this site.
01/06/2000	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/06/2000	SUPPL-13	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
01/06/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
01/06/2000	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
10/02/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/02/1995	SUPPL-7	Labeling		Label is not available on this site.

Labels for NDA 018558

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2022	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf
02/05/2020	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf
12/20/2018	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf
10/04/2018	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf
10/25/2016	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf

Therapeutic Equivalents for NDA 018558

LITHIUM CARBONATE

TABLET;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;ORAL	Prescription	Yes	AB	018558	HIKMA
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET;ORAL	Prescription	No	AB	091027	SUN PHARM INDS INC

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