Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205532
Company: HERITAGE PHARMA
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
09/29/2016 ORIG-1 Approval STANDARD

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 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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