Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205663
Company: UNIQUE PHARM LABS
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 |
---|---|---|---|---|---|
02/28/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
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 | 076691 | HIKMA |
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 |
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