Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018558
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/29/1982 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/06/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/06/2011 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

10/25/2016 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf
10/31/2007 SUPPL-19 Labeling

Label is not available on this site.

02/10/2003 SUPPL-17 Labeling

Label is not available on this site.

01/06/2000 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/06/2000 SUPPL-13 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/06/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

10/02/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/02/1995 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf

LITHIUM CARBONATE

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET;ORAL Prescription No AB 091027 SUN PHARM INDS INC
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET;ORAL Prescription Yes AB 018558 WEST-WARD PHARMS INT

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