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Generated: January 22, 2019

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Details for New Drug Application (NDA): 207042

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NDA 207042 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Amneal Pharms Co, Amphastar Pharms Inc, Dr Reddys Labs Ltd, Eurohlth Intl Sarl, Fresenius Kabi Usa, Luitpold, Par Sterile Products, and Renaissance Ssa Llc, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the NEOSTIGMINE METHYLSULFATE profile page.

The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 207042
Tradename:NEOSTIGMINE METHYLSULFATE
Applicant:Eurohlth Intl Sarl
Ingredient:neostigmine methylsulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207042
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 207042
Suppliers and Packaging for NDA: 207042
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 207042 ANDA West-Ward Pharmaceuticals Corp. 0641-6149 0641-6149-10 10 VIAL, MULTI-DOSE in 1 CARTON (0641-6149-10) > 10 mL in 1 VIAL, MULTI-DOSE (0641-6149-01)
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 207042 ANDA West-Ward Pharmaceuticals Corp. 0641-6149 0641-6149-25 25 VIAL, MULTI-DOSE in 1 CARTON (0641-6149-25) > 10 mL in 1 VIAL, MULTI-DOSE (0641-6149-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5MG/10ML (0.5MG/ML)
Approval Date:Dec 28, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:Dec 28, 2015TE:APRLD:No

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