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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 210186


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NDA 210186 describes OSELTAMIVIR PHOSPHATE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms, Epic Pharma Llc, Hainan Poly, Hetero Labs Ltd Iii, Invagen Pharms, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aptapharma Inc, Chemistry Hlth, Hetero Labs Ltd V, and Teva Pharms Usa, and is included in twenty-eight NDAs. It is available from thirty-one suppliers. Additional details are available on the OSELTAMIVIR PHOSPHATE profile page.

The generic ingredient in OSELTAMIVIR PHOSPHATE is oseltamivir phosphate. There are eight drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 210186
Tradename:OSELTAMIVIR PHOSPHATE
Applicant:Amneal Pharms Ny
Ingredient:oseltamivir phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210186
Mechanism of ActionNeuraminidase Inhibitors
Medical Subject Heading (MeSH) Categories for 210186
Suppliers and Packaging for NDA: 210186
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 210186 ANDA AvKARE 42291-567 42291-567-60 1 BOTTLE, GLASS in 1 CARTON (42291-567-60) / 60 mL in 1 BOTTLE, GLASS
OSELTAMIVIR PHOSPHATE oseltamivir phosphate FOR SUSPENSION;ORAL 210186 ANDA Amneal Pharmaceuticals NY LLC 69238-1273 69238-1273-6 1 BOTTLE, GLASS in 1 CARTON (69238-1273-6) / 60 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 6MG BASE/ML
Approval Date:Feb 27, 2018TE:ABRLD:No

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