Drugs@FDA: FDA-Approved Drugs
Company: AMNEAL PHARMS NY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 400MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/25/1986 | 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-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/26/2007 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 08/15/2006 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 05/16/2006 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/25/2001 | SUPPL-25 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-24 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1999 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/22/2000 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/24/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/19/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/11/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/26/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/05/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
IBUPROFEN
TABLET;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 214699 | ALKEM LABS LTD |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 071334 | AMNEAL PHARMS NY |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 078558 | AMNEAL PHARMS NY |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 213794 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 071267 | CONTRACT PHARMACAL |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 071268 | CONTRACT PHARMACAL |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 075682 | DR REDDYS LA |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 076112 | DR REDDYS LABS INC |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 091625 | GRANULES |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 090796 | MARKSANS PHARMA |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 202413 | SHANDONG XINHUA |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 078329 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Prescription | No | AB | 215318 | YICHANG HUMANWELL |