Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202288
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
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 |
---|---|---|---|---|---|---|---|
06/29/2012 | 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 |
---|---|---|---|---|---|
07/13/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2020 | SUPPL-3 | Labeling-Package Insert |
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 |