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FDA Approval

Neostigmine Methylsulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Dr.Reddys Laboratories Inc
DUNS: 802315887
Effective Date
July 7, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Neostigmine(1 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Dr.Reddy's Labotories Limited

Dr.Reddys Laboratories Inc

650446243

Products1

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
43598-945
Application Number
ANDA216291
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
July 7, 2022
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: 98IMH7M386Class: ACTIBQuantity: 1 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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