Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074978
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/25/1998 | ORIG-1 | Approval |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/074978Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74978ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-48 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2010 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/074978Orig1s030ltr.pdf |
| 07/31/2008 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 10/29/2003 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/25/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/074978Orig1s000lbl.pdf |
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 |