Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016980
Company: SOLVAY

Products on NDA 016980

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016980

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/24/1972	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
03/25/1994	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/25/1994	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
06/28/1994	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
04/13/1990	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/11/1990	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
12/19/1984	SUPPL-17	Labeling		Label is not available on this site.
11/15/1984	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/21/1983	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/04/1982	SUPPL-14	Labeling		Label is not available on this site.
07/23/1982	SUPPL-12	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/02/1980	SUPPL-11	Labeling		Label is not available on this site.
02/13/1979	SUPPL-8	Labeling		Label is not available on this site.
01/30/1978	SUPPL-7	Labeling		Label is not available on this site.
03/28/1980	SUPPL-6	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/19/1976	SUPPL-3	Labeling		Label is not available on this site.