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
ACEPHEN از شرکت COSETTE
Abbreviated New Drug Application (ANDA): 072344
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACEPHEN | ACETAMINOPHEN | 325MG | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/27/1992 | 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 |
|---|---|---|---|---|---|
| 04/02/2015 | SUPPL-9 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/19/2010 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
ACEPHEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUPPOSITORY;RECTAL; 325MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ACEPHEN | ACETAMINOPHEN | 325MG | SUPPOSITORY;RECTAL | Over-the-counter | No | 072344 | COSETTE |
| ACETAMINOPHEN | ACETAMINOPHEN | 325MG | SUPPOSITORY;RECTAL | Over-the-counter | Yes | 018337 | TARO PHARM INDS LTD |
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