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Neostigmine Methylsulfate

Approved
Approval ID

454d54dc-b803-4519-81e8-ac7d21e6aae1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 7, 2023

Manufacturers
FDA

Civica, Inc.

DUNS: 081373942

Products 1

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 Code72572-462
Application NumberANDA207042
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateApril 7, 2023
Generic NameNeostigmine Methylsulfate

INGREDIENTS (6)

ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NEOSTIGMINE METHYLSULFATEActive
Quantity: 1 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
PHENOLInactive
Quantity: 4.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Neostigmine Methylsulfate - FDA Drug Approval Details