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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017812
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription AB Yes No
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription AB Yes No
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;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
11/26/1980 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
10/13/2022 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017812Orig1s036,018558Orig1s030,018421Orig1s035ltr.pdf
02/05/2020 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017812Orig1s034, 018421Orig1s033, 018558Orig1s028ltr.pdf
12/20/2018 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017812Orig1s033, 018421Orig1s032, 018558Orig1s027Ltr.pdf
10/04/2018 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017812Orig1s031,018421Orig1s031,018558Orig1s026ltr.pdf
02/26/2016 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
10/20/2011 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017812s028,018421s027ltr.pdf
10/25/2016 SUPPL-27 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
10/05/2007 SUPPL-25 Labeling

Label is not available on this site.
01/31/2003 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17812slr023,18421slr021ltr.pdf
11/21/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
06/14/2001 SUPPL-21 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17812s21ltr.pdf
12/06/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
08/17/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
06/03/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
11/26/2001 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf
11/26/2001 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf
08/01/1994 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/26/2001 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf
11/26/2001 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf
02/10/1988 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
11/26/2001 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf
09/29/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
01/28/1987 SUPPL-7 Labeling

Label is not available on this site.
01/28/1987 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.
01/28/1987 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.
06/14/1983 SUPPL-4 Labeling

Label is not available on this site.
01/31/1983 SUPPL-3 Labeling

Label is not available on this site.
01/06/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
09/09/1982 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
10/13/2022 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf
02/05/2020 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf
12/20/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf
10/04/2018 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf
10/25/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017812s027,018421s025,018558s021lbl.pdf
10/20/2011 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf

LITHIUM CARBONATE

CAPSULE;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 CAPSULE;ORAL Prescription No AB 079159 ALEMBIC LTD
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription No AB 079139 GLENMARK PHARMS LTD
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription No AB 090702 HETERO LABS LTD III
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription Yes AB 017812 HIKMA

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription No AB 079159 ALEMBIC LTD
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription No AB 079139 GLENMARK PHARMS LTD
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription No AB 090702 HETERO LABS LTD III
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription Yes AB 017812 HIKMA

CAPSULE;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;ORAL Prescription No AB 079159 ALEMBIC LTD
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;ORAL Prescription No AB 079139 GLENMARK PHARMS LTD
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;ORAL Prescription No AB 090702 HETERO LABS LTD III
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;ORAL Prescription Yes AB 017812 HIKMA
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