Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076048
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | No |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | No |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;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 |
|---|---|---|---|---|---|---|---|
| 10/22/2007 | 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 |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2022 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2022 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/27/2020 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/07/2018 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/31/2018 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2015 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/12/2014 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/12/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/23/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/23/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075347 | ACTAVIS LABS FL INC |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 076048 | APOTEX |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203270 | AUROBINDO PHARMA |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203481 | BRECKENRIDGE |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075576 | DR REDDYS LABS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078490 | DR REDDYS LABS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091672 | GLENMARK PHARMS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204012 | HETERO LABS LTD III |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075785 | IMPAX LABS |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075410 | LANNETT CO INC |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075757 | SANDOZ |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212977 | XIROMED |
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091352 | ZYDUS PHARMS USA INC |
CAPSULE, DELAYED REL PELLETS;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075347 | ACTAVIS LABS FL INC |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 076048 | APOTEX |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203270 | AUROBINDO PHARMA |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203481 | BRECKENRIDGE |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075576 | DR REDDYS LABS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078490 | DR REDDYS LABS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091672 | GLENMARK PHARMS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204012 | HETERO LABS LTD III |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075785 | IMPAX LABS |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075410 | LANNETT CO INC |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075757 | SANDOZ |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204661 | TEVA PHARMS USA |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212977 | XIROMED |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091352 | ZYDUS PHARMS USA INC |
CAPSULE, DELAYED REL PELLETS;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075347 | ACTAVIS LABS FL INC |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 076048 | APOTEX |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203270 | AUROBINDO PHARMA |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203481 | BRECKENRIDGE |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075576 | DR REDDYS LABS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078490 | DR REDDYS LABS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091672 | GLENMARK PHARMS LTD |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075785 | IMPAX LABS |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 075410 | LANNETT CO INC |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 076515 | SANDOZ |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091352 | ZYDUS PHARMS USA INC |