Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205663
Company: UNIQUE PHARM LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHIUM CARBONATE LITHIUM CARBONATE 450MG 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
06/05/2017 ORIG-1 Approval 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
12/20/2018 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
12/07/2018 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LITHIUM CARBONATE

TABLET, EXTENDED RELEASE;ORAL; 450MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LITHIUM CARBONATE LITHIUM CARBONATE 450MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091616 GLENMARK GENERICS
LITHIUM CARBONATE LITHIUM CARBONATE 450MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202219 MYLAN PHARMS INC
LITHIUM CARBONATE LITHIUM CARBONATE 450MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205663 UNIQUE PHARM LABS
LITHIUM CARBONATE LITHIUM CARBONATE 450MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076691 WEST-WARD PHARMS INT

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