Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090702
Company: HETERO LABS LTD III
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 |
---|---|---|---|---|---|
10/01/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
10/01/2021 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
05/03/2018 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
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 PHARMS LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 150MG | CAPSULE;ORAL | Prescription | No | AB | 090702 | HETERO LABS LTD III |
LITHIUM CARBONATE | LITHIUM CARBONATE | 150MG | CAPSULE;ORAL | Prescription | Yes | AB | 017812 | HIKMA |
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 PHARMS LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090702 | HETERO LABS LTD III |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 017812 | HIKMA |
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 PHARMS LTD |
LITHIUM CARBONATE | LITHIUM CARBONATE | 600MG | CAPSULE;ORAL | Prescription | No | AB | 090702 | HETERO LABS LTD III |
LITHIUM CARBONATE | LITHIUM CARBONATE | 600MG | CAPSULE;ORAL | Prescription | Yes | AB | 017812 | HIKMA |