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
ACETADOTE از شرکت CUMBERLAND PHARMS
New Drug Application (NDA): 021539
Company: CUMBERLAND PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETADOTE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription |
AP |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/23/2004 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539_N-acetylcysteine_lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/27/2021 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021539s020ltr.pdf |
|
| 10/30/2019 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021539s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021539Orig1s017ltr.pdf |
||
| 01/23/2017 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021539s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021539Orig1s016ltr.pdf |
||
| 07/29/2016 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021539s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021539Orig1s015ltr.pdf |
||
| 01/15/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2013 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021539s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021539Orig1s012ltr.pdf |
||
| 01/07/2011 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021539s005ltr.pdf |
|
| 02/15/2006 | SUPPL-4 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021539s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021539s004ltr.pdf |
||
| 04/28/2004 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr002_acetadote_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539slr002ltr.pdf |
||
| 04/28/2004 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr001_acetadote_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539slr001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/30/2019 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021539s017lbl.pdf | |
| 01/23/2017 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021539s016lbl.pdf | |
| 07/29/2016 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021539s015lbl.pdf | |
| 06/05/2013 | SUPPL-12 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021539s012lbl.pdf | |
| 06/05/2013 | SUPPL-12 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021539s012lbl.pdf | |
| 02/15/2006 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021539s004lbl.pdf | |
| 04/28/2004 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr002_acetadote_lbl.pdf | |
| 04/28/2004 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr001_acetadote_lbl.pdf | |
| 01/23/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539_N-acetylcysteine_lbl.pdf |
ACETADOTE
INJECTABLE;INTRAVENOUS; 6GM/30ML (200MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETADOTE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021539 | CUMBERLAND PHARMS |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203173 | AKORN |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207358 | EUGIA PHARMA |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204797 | EXELA PHARMA |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 200644 | FRESENIUS KABI USA |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091684 | SAGENT PHARMS INC |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208166 | ZYDUS PHARMS |
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