Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090798
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | AB | No | No |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | AB | No | No |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/23/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090798Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/13/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2023 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/13/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/13/2023 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
OLANZAPINE
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 076255 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 206238 | SUNSHINE |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 091434 | TORRENT PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 076255 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 206238 | SUNSHINE |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 091434 | TORRENT PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 076255 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 206238 | SUNSHINE |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 091434 | TORRENT PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 7.5MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 076255 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 206238 | SUNSHINE |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 091434 | TORRENT PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076133 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 206238 | SUNSHINE |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 091434 | TORRENT PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 202295 | ALKEM LABS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 090798 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 202050 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 210022 | CADILA PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 203333 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 076133 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 202862 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 202287 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 204319 | QILU |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 206238 | SUNSHINE |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 091434 | TORRENT PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | No | AB | 090459 | ZYDUS PHARMS |
| ZYPREXA | OLANZAPINE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 020592 | CHEPLAPHARM |