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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202595

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NDA 202595 describes OSELTAMIVIR PHOSPHATE, which is a drug marketed by Amneal Pharms, Lupin Atlantis, Macleods Pharms Ltd, Natco Pharma Ltd, Nesher Pharms, and Alvogen Pine Brook, and is included in seven NDAs. It is available from thirteen suppliers. Additional details are available on the OSELTAMIVIR PHOSPHATE profile page.

The generic ingredient in OSELTAMIVIR PHOSPHATE is oseltamivir phosphate. There are seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 202595
Applicant:Natco Pharma Ltd
Ingredient:oseltamivir phosphate
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202595
Suppliers and Packaging for NDA: 202595
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 202595 ANDA Alvogen Inc. 47781-468 N 47781-468-13
OSELTAMIVIR PHOSPHATE oseltamivir phosphate CAPSULE;ORAL 202595 ANDA Alvogen Inc. 47781-469 N 47781-469-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 30MG BASE
Approval Date:Aug 3, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 45MG BASE
Approval Date:Aug 3, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Aug 3, 2016TE:ABRLD:No

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