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 AUROBINDO PHARMA LTD
Abbreviated New Drug Application (ANDA): 207229
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 11/09/2016 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
ACETAMINOPHEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 650MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207229 | AUROBINDO PHARMA LTD |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 211544 | GRANULES |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207035 | HERITAGE PHARMA |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215486 | MARKSANS PHARMA |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 076200 | OHM LABS |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075077 | PERRIGO |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 078569 | SUN PHARM INDS LTD |
| TYLENOL | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 019872 | J AND J CONSUMER INC |
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