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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208166
Company: ZYDUS PHARMS

Products on ANDA 208166

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 208166

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/04/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208166

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	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
ACETYLCYSTEINE	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	217182	ONESOURCE SPECIALTY
ACETYLCYSTEINE	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215620	REGCON HOLDINGS
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	208166	ZYDUS PHARMS

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