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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021539
Company: CUMBERLAND PHARMS

Products on NDA 021539

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021539

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-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

Labels for NDA 021539

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-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

Therapeutic Equivalents for NDA 021539

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	213693	ASPEN
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	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	217182	STERISCIENCE
ACETYLCYSTEINE	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	208166	ZYDUS PHARMS

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