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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207042
Company: HIKMA

Products on ANDA 207042

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207042

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 207042

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

Therapeutic Equivalents for ANDA 207042

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	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	213244	EUGIA PHARMA
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	208405	PAR STERILE PRODUCTS
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	213244	EUGIA PHARMA
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	208405	PAR STERILE PRODUCTS
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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