U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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
Back to Top