Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016782
Company: SOLVAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Discontinued None No No
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.

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