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 | 800MG | 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 |
---|---|---|---|---|---|---|---|
10/13/1987 | 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 |
---|---|---|---|---|---|
04/28/2021 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/22/2019 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
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05/09/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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12/26/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
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08/07/2006 | SUPPL-23 | Labeling |
Label is not available on this site. |
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07/03/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
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09/25/2001 | SUPPL-17 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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04/12/2000 | SUPPL-16 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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04/12/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/30/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
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04/12/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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09/24/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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02/11/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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07/24/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/20/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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01/30/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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06/30/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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03/28/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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02/17/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/17/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
IBUPROFEN
TABLET;ORAL; 800MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 214699 | ALKEM LABS LTD |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 071935 | AMNEAL PHARMS NY |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 078558 | AMNEAL PHARMS NY |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 213794 | AUROBINDO PHARMA LTD |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 071268 | CONTRACT PHARMACAL |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 072300 | CONTRACT PHARMACAL |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 075682 | DR REDDYS LA |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 076112 | DR REDDYS LABS INC |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 091625 | GRANULES |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 090796 | MARKSANS PHARMA |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 202413 | SHANDONG XINHUA |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 078329 | STRIDES PHARMA |
IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL | Prescription | No | AB | 215318 | YICHANG HUMANWELL |