Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079058
Company: TRIS PHARMA INC
Company: TRIS PHARMA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;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 |
---|---|---|---|---|---|---|---|
08/31/2009 | 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 |
---|---|---|---|---|---|
05/10/2017 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/10/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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05/10/2017 | SUPPL-2 | Labeling-Package Insert |
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.
SUSPENSION/DROPS;ORAL; 40MG/ML
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CHILDREN'S MOTRIN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | Yes | 020603 | J AND J CONSUMER INC |
IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | No | 213506 | AUROBINDO PHARMA LTD |
IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | No | 210755 | GUARDIAN DRUG |
IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | No | 075217 | L PERRIGO CO |
IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | No | 217261 | TARO |
IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | No | 079058 | TRIS PHARMA INC |