Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075347
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| 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 |
|---|---|---|---|---|---|---|---|
| 05/30/2008 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75347ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75347ltr.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075347.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/04/2022 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2020 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2018 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2018 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/31/2018 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/01/2015 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/01/2015 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/17/2012 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/09/2012 | SUPPL-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2012 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/04/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/04/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/24/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/31/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
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 | 212977 | XIROMED |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091352 | ZYDUS PHARMS USA INC |