Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207042
Company: EUROHLTH INTL SARL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;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
12/28/2015 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207042Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/28/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207042lbl.pdf

NEOSTIGMINE METHYLSULFATE

SOLUTION;INTRAVENOUS; 5MG/10ML (0.5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BLOXIVERZ NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204078 AVADEL LEGACY
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210051 AMNEAL PHARMS CO
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209933 AMPHASTAR PHARMS INC
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210989 AMRING PHARMS
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212512 BE PHARMS
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209135 DR REDDYS LABS LTD
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207042 EUROHLTH INTL SARL
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209182 LUITPOLD
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208405 PAR STERILE PRODUCTS

SOLUTION;INTRAVENOUS; 10MG/10ML (1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BLOXIVERZ NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204078 AVADEL LEGACY
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210051 AMNEAL PHARMS CO
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209933 AMPHASTAR PHARMS INC
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210989 AMRING PHARMS
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212512 BE PHARMS
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209135 DR REDDYS LABS LTD
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207042 EUROHLTH INTL SARL
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209182 LUITPOLD
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208405 PAR STERILE PRODUCTS

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