Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Hikma Pharmaceuticals USA Inc.
946499746
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc.
946499746
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neostigmine Methylsulfate
Product Details
NDC Product Code
0641-6265Application Number
ANDA207042Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
April 7, 2023NeostigmineActive
Code: 98IMH7M386Class: ACTIBQuantity: 1 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 4.5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.2 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
Neostigmine Methylsulfate
Product Details
NDC Product Code
0641-6264Application Number
ANDA207042Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
April 7, 2023PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 4.5 mg in 1 mL
NeostigmineActive
Code: 98IMH7M386Class: ACTIBQuantity: 0.5 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.2 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT