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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200644
Company: FRESENIUS KABI USA

Products on ANDA 200644

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETYLCYSTEINE	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200644

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2012	ORIG-1	Approval	Not Applicable		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200644Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2016	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 200644

ACETYLCYSTEINE

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	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	091684	SAGENT PHARMS INC
ACETYLCYSTEINE	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	208166	ZYDUS PHARMS

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