NDC 70720-950

ZOLADEX

Goserelin Acetate

ZOLADEX is a Subcutaneous Implant in the Human Prescription Drug category. It is labeled and distributed by Tersera Therapeutics Llc. The primary component is Goserelin Acetate.

Product ID70720-950_3f088f3c-f0f5-452c-b331-d83360ceae60
NDC70720-950
Product TypeHuman Prescription Drug
Proprietary NameZOLADEX
Generic NameGoserelin Acetate
Dosage FormImplant
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-03-31
Marketing CategoryNDA / NDA
Application NumberNDA019726
Labeler NameTerSera Therapeutics LLC
Substance NameGOSERELIN ACETATE
Active Ingredient Strength4 mg/1
Pharm ClassesGonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70720-950-36

1 POUCH in 1 CARTON (70720-950-36) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE
Marketing Start Date2018-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70720-950-36 [70720095036]

ZOLADEX IMPLANT
Marketing CategoryNDA
Application NumberNDA019726
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-31

Drug Details

Active Ingredients

IngredientStrength
GOSERELIN ACETATE3.6 mg/1

Pharmacological Class

  • Gonadotropin Releasing Hormone Receptor Agonist [EPC]
  • Gonadotropin Releasing Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "ZOLADEX" or generic name "Goserelin Acetate"

NDCBrand NameGeneric Name
0310-0950ZOLADEXGoserelin acetate
0310-0951ZOLADEXGoserelin acetate
50090-2027ZOLADEXGoserelin acetate
50090-3466ZOLADEXgoserelin acetate
70720-950ZOLADEXgoserelin acetate
70720-951ZOLADEXgoserelin acetate

Trademark Results [ZOLADEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZOLADEX
ZOLADEX
74588633 1938346 Dead/Cancelled
Zeneca Limited
1994-10-21
ZOLADEX
ZOLADEX
74324147 1885525 Dead/Cancelled
Zeneca Limited
1992-10-21
ZOLADEX
ZOLADEX
74010646 1624402 Live/Registered
IMPERIAL CHEMICAL INDUSTRIES PLC
1989-12-14
ZOLADEX
ZOLADEX
73545833 1402790 Live/Registered
IMPERIAL CHEMICAL INDUSTRIES PLC
1985-07-01

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