Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076243
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE;ORAL Prescription AB No No
LITHIUM CARBONATE LITHIUM CARBONATE 150MG 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
06/27/2002 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076243_S000_LithiumTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/14/2016 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

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

Label is not available on this site.

02/24/2003 SUPPL-2 Labeling

Label is not available on this site.

02/24/2003 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

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 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; 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

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