Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076925
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 09/23/2004 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2017 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-33 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2013 | SUPPL-29 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/04/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/03/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/22/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
IBUPROFEN
SUSPENSION;ORAL; 100MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 074978 | ACTAVIS MID ATLANTIC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209178 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 076925 | PADAGIS US |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 215311 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209204 | TARO |