Drugs@FDA: FDA-Approved Drugs
Company: L PERRIGO CO
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 |
---|---|---|---|---|---|---|---|
12/16/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75217ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/24/2011 | SUPPL-38 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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03/22/2006 | SUPPL-26 | Labeling |
Label is not available on this site. |
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05/22/2003 | SUPPL-9 | Labeling |
Label is not available on this site. |
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08/21/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/14/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/18/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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05/24/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
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05/24/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/16/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen_prntlbl.pdf |
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 |