Drugs@FDA: FDA-Approved Drugs
Company: CONTRACT PHARMACAL
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 |
---|---|---|---|---|---|---|---|
10/15/1986 | 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 |
---|---|---|---|---|---|
05/09/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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01/23/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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08/10/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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12/18/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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12/18/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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12/18/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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07/06/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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07/06/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/06/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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10/02/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/14/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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05/14/1987 | 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 |