NDC 61269-410

ETOPOPHOS

Etoposide Phosphate

ETOPOPHOS is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by H2-pharma, Llc. The primary component is Etoposide Phosphate.

Product ID61269-410_34466284-8d9f-4d2e-88a4-5ca30df0d743
NDC61269-410
Product TypeHuman Prescription Drug
Proprietary NameETOPOPHOS
Generic NameEtoposide Phosphate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-06-01
Marketing CategoryNDA / NDA
Application NumberNDA020457
Labeler NameH2-Pharma, LLC
Substance NameETOPOSIDE PHOSPHATE
Active Ingredient Strength100 mg/1
Pharm ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61269-410-20

1 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2009-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61269-410-20 [61269041020]

ETOPOPHOS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA020457
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01

Drug Details

Active Ingredients

IngredientStrength
ETOPOSIDE PHOSPHATE100 mg/1

Pharmacological Class

  • Topoisomerase Inhibitor [EPC]
  • Topoisomerase Inhibitors [MoA]
  • Topoisomerase Inhibitor [EPC]
  • Topoisomerase Inhibitors [MoA]

NDC Crossover Matching brand name "ETOPOPHOS" or generic name "Etoposide Phosphate"

NDCBrand NameGeneric Name
0015-3404ETOPOPHOSetoposide phosphate
61269-410ETOPOPHOSetoposide phosphate

Trademark Results [ETOPOPHOS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ETOPOPHOS
ETOPOPHOS
74179774 1757537 Live/Registered
CHEPLAPHARM ARZNEIMITTEL GMBH
1991-06-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.