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 OHM LABS
Abbreviated New Drug Application (ANDA): 076200
Company: OHM LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 03/19/2002 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76200.apd.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/23/2015 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-21 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-19 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/28/2010 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/22/2010 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/23/2009 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/17/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/11/2004 | SUPPL-5 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076200_S005_AcetaminophenTOC.cfm |
||
| 12/03/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm |
|
| 12/03/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm |
|
| 12/03/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm |
|
| 10/15/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001_AcetaminophenTOC.cfm |
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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