Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017971
Company: JDS PHARMS

Products on NDA 017971

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESKALITH	LITHIUM CARBONATE	300MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017971

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/1979	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		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
07/29/1987	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/27/1983	SUPPL-9	Labeling		Label is not available on this site.
04/29/1982	SUPPL-8	Labeling		Label is not available on this site.
12/02/1981	SUPPL-7	Labeling		Label is not available on this site.
11/24/1981	SUPPL-6	Labeling		Label is not available on this site.
09/11/1981	SUPPL-5	Labeling		Label is not available on this site.
09/19/1980	SUPPL-3	Labeling		Label is not available on this site.
02/06/1980	SUPPL-2	Labeling		Label is not available on this site.
09/20/1979	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 017971

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