FDA Product

FULVESTRANT

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

FULVESTRANT

FDA Product Code

70771-1626

Regulatory Information

NDC Product Code

70771-1626

Application Number

ANDA215234

Marketing Category

C73584

Effective Date

August 26, 2022

Territorial Authority

USA

FDA Title

Fulvestrant Injection

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerZydus Lifesciences Limited

DUNS Number

918596198

Active Ingredients

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

BENZYL BENZOATE

Code: N863NB338G

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

CASTOR OIL

Code: D5340Y2I9G

Class Code: IACT

Quantity: 50 mg in 1 mL

Code: 22X328QOC4

Class Code: ACTIB

Active Moieties

FULVESTRANT

Code: 22X328QOC4

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