Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076170
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;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
06/10/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76170_Lithium%20Carbonate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76170_Lithium%20Carbonate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076170_lithium_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/17/2003 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76170_Lithium%20Carbonate_Prntlbl.pdf

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