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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207358
Company: EUGIA PHARMA
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
02/29/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207358Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2020 SUPPL-1 Labeling-Package Insert

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 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 218397 SOMERSET THERAPS LLC
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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