Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203624
Company: MYLAN INSTITUTIONAL
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/19/2015 ORIG-1 Approval

Label is not available on this site.

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 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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