Drugs@FDA: FDA Approved Drug Products

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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 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
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-Container/Carton Labels, Labeling-Patient Package Insert 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
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021539s012lbl.pdf
06/05/2013 SUPPL-12 Labeling-Patient Package Insert 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 INC
ACETYLCYSTEINE ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207358 AUROBINDO PHARMA LTD
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 203624 MYLAN INSTITUTIONAL
ACETYLCYSTEINE ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 091684 SAGENT PHARMS

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