Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091434
Company: TORRENT PHARMS LTD
Company: TORRENT PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Discontinued | None | No | No |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/23/2012 | 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 |
|---|---|---|---|---|---|
| 07/13/2022 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/13/2022 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 07/13/2022 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 07/13/2022 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 07/13/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/13/2022 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2014 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |