Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076121
Company: ABLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CARBONATE 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
09/27/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76121d.apf.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076121.PDF

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