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 TARO PHARM INDS LTD
New Drug Application (NDA): 018337
Company: TARO PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | SUPPOSITORY;RECTAL | Over-the-counter |
None |
Yes | Yes |
| ACETAMINOPHEN | ACETAMINOPHEN | 325MG | SUPPOSITORY;RECTAL | Over-the-counter |
None |
Yes | No |
| ACETAMINOPHEN | ACETAMINOPHEN | 120MG | SUPPOSITORY;RECTAL | Over-the-counter |
None |
Yes | No |
| INFANTS’ FEVERALL | ACETAMINOPHEN | 80MG | SUPPOSITORY;RECTAL | Over-the-counter |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/22/1980 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/07/2020 | SUPPL-35 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018337Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018337Orig1s035ltr.pdf |
||
| 08/12/2015 | SUPPL-34 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018337Orig1s034ltr.pdf |
||
| 01/05/2015 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/2014 | SUPPL-32 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018337Orig1s032ltr.pdf |
||
| 10/20/2010 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 04/05/2010 | SUPPL-28 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018337s028ltr.pdf |
|
| 06/27/2008 | SUPPL-25 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018337s025ltr.pdf |
|
| 11/02/2007 | SUPPL-24 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018337s024ltr.pdf |
|
| 10/09/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018337Orig1s013.pdf |
|
| 01/28/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/07/2020 | SUPPL-35 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018337Orig1s035lbl.pdf | |
| 08/12/2015 | SUPPL-34 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf | |
| 01/16/2014 | SUPPL-32 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf |
ACETAMINOPHEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUPPOSITORY;RECTAL; 650MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ACEPHEN | ACETAMINOPHEN | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | No | 072237 | COSETTE |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | No | 070608 | PERRIGO NEW YORK |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | Yes | 018337 | TARO PHARM INDS LTD |
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 |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUPPOSITORY;RECTAL; 120MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ACEPHEN | ACETAMINOPHEN | 120MG | SUPPOSITORY;RECTAL | Over-the-counter | No | 018060 | COSETTE |
| ACETAMINOPHEN | ACETAMINOPHEN | 120MG | SUPPOSITORY;RECTAL | Over-the-counter | No | 070607 | PERRIGO NEW YORK |
| ACETAMINOPHEN | ACETAMINOPHEN | 120MG | SUPPOSITORY;RECTAL | Over-the-counter | Yes | 018337 | TARO PHARM INDS LTD |
INFANTS’ FEVERALL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUPPOSITORY;RECTAL; 80MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| INFANTS’ FEVERALL | ACETAMINOPHEN | 80MG | SUPPOSITORY;RECTAL | Over-the-counter | Yes | 018337 | TARO PHARM INDS LTD |
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