Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076925
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
09/23/2004 | 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-47 | Labeling-Package Insert |
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. |
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04/18/2017 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/09/2016 | SUPPL-33 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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08/13/2013 | SUPPL-29 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/04/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
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07/03/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
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03/22/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
IBUPROFEN
SUSPENSION;ORAL; 100MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 074978 | ACTAVIS MID ATLANTIC |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209178 | AUROBINDO PHARMA LTD |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 076925 | PADAGIS US |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 215311 | STRIDES PHARMA |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209204 | TARO |