Orange Book product · Brand (NDA)
TAMIFLU
OSELTAMIVIR PHOSPHATE
At a glance
Oct 27, 1999
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 27, 1999
27 yr ago
Today
Pharmaceutical detail
Active ingredient
OSELTAMIVIR PHOSPHATE
Strength
EQ 75MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 021087
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2011TAMIFLUBrand (NDA)
NDA 021246 · ROCHE
- 2026OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 213437 · UPSHER SMITH LABS
- 2025OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 218009 · ZHEJIANG POLY PHARM
- 2025OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 217274 · SHANDONG
- 2025OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 213695 · JUBILANT GENERICS
- 2024OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 217451 · CEDIPROF INC
- 2024OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 217133 · BEIJING JIALIN
- 2024OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 217303 · PHARMOBEDIENT
- 2024OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 218131 · AUROBINDO PHARMA LTD
- 2024OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 218565 · LAURUS
- 2023OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 217467 · INVAGEN PHARMS
- 2023OSELTAMIVIR PHOSPHATEGeneric (ANDA)
ANDA 215538 · EPIC PHARMA LLC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
