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
ACETAMINOPHEN, ASPIRIN AND CAFFEINE از شرکت PERRIGO
Abbreviated New Drug Application (ANDA): 075794
Company: PERRIGO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/26/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75794apdF.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/26/2016 | SUPPL-45 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/12/2014 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2010 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/21/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/17/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/08/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/16/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/16/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/16/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/16/2002 | SUPPL-1 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 250MG;250MG;65MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;ORAL | Over-the-counter | No | 214039 | GRANULES |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;ORAL | Over-the-counter | No | 075794 | PERRIGO |
| EXCEDRIN (MIGRAINE) | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;ORAL | Over-the-counter | Yes | 020802 | GLAXOSMITHKLINE CONS |
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