Drugs@FDA: FDA-Approved Drugs
Company: AMNEAL PHARMS NY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG | TABLET;ORAL | Prescription | AB | No | Yes |
| HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 5MG;200MG | TABLET;ORAL | Prescription | AB | No | No |
| REPREXAIN | HYDROCODONE BITARTRATE; IBUPROFEN | 2.5MG;200MG | TABLET;ORAL | Discontinued | None | No | No |
| REPREXAIN | HYDROCODONE BITARTRATE; IBUPROFEN | 10MG;200MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/18/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076642_original_approval_pkg.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/18/2023 | SUPPL-42 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/18/2023 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-35 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2019 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-25 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/15/2018 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/15/2018 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/15/2018 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2008 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/04/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/03/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/19/2007 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf |
| 10/19/2007 | SUPPL-7 | Manufacturing (CMC)-New Strength |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf |
| 10/19/2007 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf |
| 10/19/2007 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf |
| 10/12/2004 | SUPPL-3 |
Label is not available on this site. |
|||
| 06/16/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/05/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |
HYDROCODONE BITARTRATE AND IBUPROFEN
TABLET;ORAL; 7.5MG;200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG | TABLET;ORAL | Prescription | No | AB | 076604 | ACTAVIS LABS FL INC |
| HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG | TABLET;ORAL | Prescription | No | AB | 076642 | AMNEAL PHARMS NY |
| HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG | TABLET;ORAL | Prescription | No | AB | 204575 | AUROLIFE PHARMA LLC |
| HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG | TABLET;ORAL | Prescription | No | AB | 077723 | NOSTRUM LABS INC |
TABLET;ORAL; 5MG;200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE | HYDROCODONE BITARTRATE; IBUPROFEN | 5MG;200MG | TABLET;ORAL | Prescription | No | AB | 077723 | NOSTRUM LABS INC |
| HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 5MG;200MG | TABLET;ORAL | Prescription | No | AB | 076642 | AMNEAL PHARMS NY |
REPREXAIN
There are no Therapeutic Equivalents.