Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076604
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/2003 | 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/11/2019 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/23/2019 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-20 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 03/22/2017 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/22/2017 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2007 | SUPPL-4 | 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 |