Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021539
Company: CUMBERLAND PHARMS
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 |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539_N-acetylcysteine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-539_Acetadote.cfm |
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 |
Letter (PDF)
|
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021539s005ltr.pdf |
02/15/2006 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 | 207358 | EUGIA 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 | 213693 | GLENMARK PHARMS INC |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215620 | INDOCO |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203173 | RISING |
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 | 218397 | SOMERSET THERAPS LLC |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 217182 | STERISCIENCE SPECLTS |
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208166 | ZYDUS PHARMS |