Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017971
Company: JDS PHARMS
Company: JDS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESKALITH | LITHIUM CARBONATE | 300MG | TABLET;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 |
---|---|---|---|---|---|---|---|
02/26/1979 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/11/2004 | SUPPL-20 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16860slr074,18152slr020ltr.pdf | ||
07/29/1987 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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01/27/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/29/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/02/1981 | SUPPL-7 | Labeling |
Label is not available on this site. |
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11/24/1981 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/11/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/19/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
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02/06/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
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09/20/1979 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/11/2004 | SUPPL-20 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf |