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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018152
Company: JDS PHARMS

Products on NDA 018152

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESKALITH CR	LITHIUM CARBONATE	450MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018152

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/1982	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
03/11/2004	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16860slr074,18152slr020ltr.pdf
10/15/2002	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
08/05/2002	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860slr073,17971slr019,18152slr017ltr.pdf
05/08/2002	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf
04/06/2000	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/21/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/08/2002	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf
05/08/2002	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf
10/20/1995	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/08/2002	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf
05/08/2002	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf
05/08/2002	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf
01/27/1983	SUPPL-2	Labeling		Label is not available on this site.
04/29/1982	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018152

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2004	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf

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