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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204078
Company: EXELA PHARMA

Summary Review

Products on NDA 204078

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
BLOXIVERZ	NEOSTIGMINE METHYLSULFATE	5MG/5ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204078

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
10/27/2023	SUPPL-14	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204078Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204078Orig1s014ltr.pdf
01/19/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204078s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204078orig1s010ltr.pdf
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.

Labels for NDA 204078

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/27/2023	SUPPL-14	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204078Orig1s014lbl.pdf
01/19/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204078s010lbl.pdf
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

Therapeutic Equivalents for NDA 204078

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	EXELA PHARMA
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	213074	CAPLIN
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	208405	ENDO OPERATIONS
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	207042	HIKMA
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	210652	INDOCO
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212804	MEITHEAL
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212627	NIVAGEN PHARMS INC
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216542	SAGENT PHARMS INC
NEOSTIGMINE METHYSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208230	AVET LIFESCIENCES

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	EXELA PHARMA
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	213074	CAPLIN
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	208405	ENDO OPERATIONS
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	207042	HIKMA
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	210652	INDOCO
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212804	MEITHEAL
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212627	NIVAGEN PHARMS INC
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216542	SAGENT PHARMS INC
NEOSTIGMINE METHYSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208230	AVET LIFESCIENCES

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