Details for New Drug Application (NDA): 218009

NDA 218009 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, 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-one 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 218009

Tradename:	OSELTAMIVIR PHOSPHATE
Applicant:	Hainan Poly
Ingredient:	oseltamivir phosphate
Patents:	0

Pharmacology for NDA: 218009

Mechanism of Action

Neuraminidase Inhibitors

Medical Subject Heading (MeSH) Categories for 218009

Antiviral Agents

Enzyme Inhibitors

Suppliers and Packaging for NDA: 218009

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	218009	ANDA	Hainan Poly Pharm. Co., Ltd.	14335-380	14335-380-01	1 BLISTER PACK in 1 CARTON (14335-380-01) / 10 CAPSULE in 1 BLISTER PACK
OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	218009	ANDA	Slate Run Pharmaceuticals, LLC	70436-225	70436-225-47	1 BLISTER PACK in 1 CARTON (70436-225-47) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Nov 24, 2023	TE:	AB	RLD:	No

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