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 | 200MG | TABLET;ORAL | Over-the-counter | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/17/1987 | 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 |
|---|---|---|---|---|---|
| 05/08/2011 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2012 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 08/21/2008 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 05/09/2006 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/16/2005 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 10/22/2002 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 09/25/2001 | SUPPL-25 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 03/13/2001 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/04/2000 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-21 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 09/13/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/24/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/25/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/25/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/20/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1988 | 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
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | Yes | 018989 | HALEON US HOLDINGS |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079233 | AMNEAL PHARMS |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 071333 | AMNEAL PHARMS NY |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072199 | AMNEAL PHARMS NY |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 208865 | AUROBINDO PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 076460 | AVEMA PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072299 | CONTRACT PHARMACAL |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075661 | DR REDDYS LA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 076117 | DR REDDYS LABS INC |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 202312 | GRANULES |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079174 | GRANULES INDIA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075010 | LNK |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075139 | LNK |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091237 | MARKSANS PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091239 | MARKSANS PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 073019 | MCNEIL |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072096 | PERRIGO |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 077349 | PERRIGO R AND D |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 207095 | SHANDONG XINHUA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 070481 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079129 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091355 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 206989 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 207052 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 071229 | VINTAGE PHARMS |
| MOTRIN IB | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | Yes | 019012 | J AND J CONSUMER INC |