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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076832
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
10/28/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2004/076832Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/14/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/14/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

02/14/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/06/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/26/2007 SUPPL-5 Labeling

Label is not available on this site.

09/28/2007 SUPPL-3 Labeling

Label is not available on this site.

LITHIUM CARBONATE

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 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 076832 HIKMA
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
LITHOBID LITHIUM CARBONATE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 018027 ANI PHARMS
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