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 از شرکت SANDOZ INC
Abbreviated New Drug Application (ANDA): 204052
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 03/22/2016 | 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 |
|---|---|---|---|---|---|
| 07/24/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ACETAMINOPHEN
SOLUTION;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214331 | BAXTER HLTHCARE CORP |
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202605 | CUSTOPHARM INC |
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210969 | EUGIA PHARMA |
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213255 | MYLAN |
| ACETAMINOPHEN | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204052 | SANDOZ INC |
| OFIRMEV | ACETAMINOPHEN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022450 | MALLINCKRODT HOSP |
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