Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204078
Company: AVADEL LEGACY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BLOXIVERZ NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
BLOXIVERZ NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/31/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204078s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204078Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204078Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204078Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/20/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204078s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204078Orig1s007ltr.pdf
12/02/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/11/2014 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204078s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204078Orig1s004ltr.pdf
09/22/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/18/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/20/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204078s007lbl.pdf
12/11/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204078s004lbl.pdf
05/31/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204078s000lbl.pdf

BLOXIVERZ

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 209182 AM REGENT
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210051 AMNEAL
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
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 212968 GLAND PHARMA LTD
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 209182 AM REGENT
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210051 AMNEAL
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
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 212968 GLAND PHARMA LTD
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208405 PAR STERILE PRODUCTS

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