Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016782
Company: SOLVAY

Products on NDA 016782

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016782

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/1970	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/1993	SUPPL-39	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/16/1992	SUPPL-37	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/28/1994	SUPPL-35	Manufacturing (CMC)-Control		Label is not available on this site.
04/11/1990	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
11/18/1988	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
11/18/1988	SUPPL-31	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/18/1988	SUPPL-30	Labeling		Label is not available on this site.
12/19/1984	SUPPL-28	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/19/1984	SUPPL-27	Labeling		Label is not available on this site.
12/19/1984	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/04/1982	SUPPL-25	Labeling		Label is not available on this site.
07/23/1982	SUPPL-23	Manufacturing (CMC)-Formulation		Label is not available on this site.
07/23/1982	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
10/02/1980	SUPPL-21	Labeling		Label is not available on this site.
02/22/1979	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/23/1979	SUPPL-18	Labeling		Label is not available on this site.
01/26/1978	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/01/1977	SUPPL-16	Labeling		Label is not available on this site.
06/03/1976	SUPPL-15	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/02/1976	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
07/01/1975	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.