Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091038
Company: SUN PHARM INDS
Company: SUN PHARM INDS
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 |
---|---|---|---|---|---|
06/17/2021 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/19/2015 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/19/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/19/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |