Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018027
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHOBID LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;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
04/27/1979 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
12/20/2018 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018027Orig1s065Ltr.pdf
04/30/2018 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018027Orig1s064ltr.pdf
05/27/2016 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018027s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018027Orig1s059ltr.pdf
05/11/2015 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

10/20/2011 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018027s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018027s056ltr.pdf
10/01/2006 SUPPL-55 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018027s055LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018027_s055_lithobid_LBL.pdf
04/07/2006 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018027s051ltr.pdf
10/07/2002 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf
10/16/2001 SUPPL-48 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/22/2000 SUPPL-47 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/07/2002 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf
07/11/1997 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/26/1995 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/2002 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf
05/02/1990 SUPPL-37 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/07/2002 SUPPL-35 Labeling

Label is not available on this site.

04/20/1990 SUPPL-34 Labeling

Label is not available on this site.

10/13/1988 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/13/1988 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1988 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/07/1989 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/2002 SUPPL-27 Labeling

Label is not available on this site.

10/07/2002 SUPPL-25 Labeling

Label is not available on this site.

05/01/1986 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/29/1985 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1983 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/25/1983 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/19/1982 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/1981 SUPPL-16 Labeling

Label is not available on this site.

08/06/1981 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/1981 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/02/1980 SUPPL-10 Labeling

Label is not available on this site.

05/13/1980 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/26/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/03/1979 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/03/1979 SUPPL-4 Labeling

Label is not available on this site.

01/04/1980 SUPPL-3 Labeling

Label is not available on this site.

10/03/1979 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/13/1979 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
12/20/2018 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s065lbl.pdf
04/30/2018 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018027s064lbl.pdf
05/27/2016 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018027s059lbl.pdf
10/20/2011 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018027s056lbl.pdf
10/07/2002 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf
10/07/2002 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf
10/07/2002 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf

LITHOBID

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 204445 ALEMBIC PHARMS LTD
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091544 GLENMARK PHARMS INC
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205532 HERITAGE PHARMA
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202288 MYLAN PHARMS INC
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204779 UNIQUE PHARM LABS
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076832 WEST-WARD PHARMS INT
LITHOBID LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 018027 ANI PHARMS INC

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