Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076832
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | 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 |
---|---|---|---|---|---|---|---|
10/28/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2004/076832Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/14/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
02/14/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
02/14/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
12/26/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
09/28/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
LITHIUM CARBONATE
TABLET, EXTENDED RELEASE;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 | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091544 | GLENMARK PHARMS INC |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205532 | HERITAGE PHARMA |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076832 | HIKMA |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202288 | MYLAN PHARMS INC |
LITHIUM CARBONATE | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204779 | UNIQUE |
LITHOBID | LITHIUM CARBONATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 018027 | ANI PHARMS |