اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CHILDREN’S IBUPROFEN از شرکت PERRIGO
Abbreviated New Drug Application (ANDA): 074937
Company: PERRIGO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 12/22/1998 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-937_Ibuprofen_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/18/2011 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/17/2006 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 08/02/2002 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/26/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/2001 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/21/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-19 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-14 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-9 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-937_Ibuprofen_prntlbl.pdf |
CHILDREN’S IBUPROFEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 100MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | GLAXOSMITHKLINE |
| CHILDREN’S ADVIL-FLAVORED | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | GLAXOSMITHKLINE |
| CHILDREN’S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074937 | PERRIGO |
| CHILDREN’S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 020516 | J AND J CONSUMER INC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210602 | APTAPHARMA INC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 200457 | ARISE |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209179 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210149 | GUARDIAN DRUG |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074916 | P AND L |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 211666 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209207 | TARO |
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