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 | 600MG | 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-42 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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07/22/2019 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-39 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/26/2007 | SUPPL-35 | Labeling |
Label is not available on this site. |
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08/15/2006 | SUPPL-31 | Labeling |
Label is not available on this site. |
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05/16/2006 | SUPPL-30 | 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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04/12/2000 | SUPPL-24 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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04/12/2000 | 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. |
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04/12/2000 | 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. |
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02/11/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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07/24/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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01/20/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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01/30/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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01/19/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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10/11/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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03/28/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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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. |
||
01/07/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/12/1988 | 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. |
||
06/24/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
IBUPROFEN
TABLET;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 214699 | ALKEM LABS LTD |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 071335 | AMNEAL PHARMS NY |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 078558 | AMNEAL PHARMS NY |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 213794 | AUROBINDO PHARMA LTD |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 071268 | CONTRACT PHARMACAL |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 075682 | DR REDDYS LA |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 076112 | DR REDDYS LABS INC |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 091625 | GRANULES |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 090796 | MARKSANS PHARMA |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 202413 | SHANDONG XINHUA |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 078329 | STRIDES PHARMA |
IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 215318 | YICHANG HUMANWELL |