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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 217303

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NDA 217303 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, Laurus, Lupin, Macleods Pharms Ltd, MSN, Nanjing Daoqun, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Leading, Oryza, and Teva Pharms Usa, and is included in thirty-two NDAs. It is available from thirty-four 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-five suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.

Summary for 217303

Tradename:	OSELTAMIVIR PHOSPHATE
Applicant:	Oryza
Ingredient:	oseltamivir phosphate
Patents:	0

Medical Subject Heading (MeSH) Categories for 217303

Antiviral Agents
Enzyme Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 6MG BASE/ML
Approval Date:	Jul 2, 2024	TE:	AB	RLD:	No

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