Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203629
Company: FRESENIUS KABI USA

• Summary Review

Products on NDA 203629

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	None	Yes	Yes
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203629

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/08/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203629s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203629Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203629s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203629Orig1s003ltr.pdf
07/31/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203629

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203629s003lbl.pdf
01/08/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203629s000lbl.pdf

Therapeutic Equivalents for NDA 203629

NEOSTIGMINE METHYLSULFATE

SOLUTION;INTRAVENOUS; 3MG/3ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216291	DR REDDYS
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	203629	FRESENIUS KABI USA
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216206	HIKMA