Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090702
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription AB No No
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription AB No No
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;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
09/25/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/06/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

LITHIUM CARBONATE

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 GENERICS
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription No AB 090702 HETERO LABS LTD III
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription No AB 076243 MYLAN PHARMS INC
LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE;ORAL Prescription Yes AB 017812 WEST-WARD PHARMS INT

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 GENERICS
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription No AB 090702 HETERO LABS LTD III
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription No AB 076243 MYLAN PHARMS INC
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription Yes AB 017812 WEST-WARD PHARMS INT

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 GENERICS
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;ORAL Prescription No AB 090702 HETERO LABS LTD III
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;ORAL Prescription No AB 078763 MYLAN PHARMS INC
LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE;ORAL Prescription Yes AB 017812 WEST-WARD PHARMS INT

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