Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204575
Company: AUROLIFE PHARMA LLC
Company: AUROLIFE PHARMA LLC
| 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 |
|---|---|---|---|---|---|---|---|
| 06/02/2016 | 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-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 03/04/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 10/11/2019 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-2 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/15/2018 | SUPPL-1 | Labeling-Package Insert |
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 |