Ella

Ella

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 081160441

Effective Date

November 1, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ulipristal(30 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

73302-456

Application Number

NDA022474

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 1, 2023

Ingredients

Code: YF7V70N02BClass: ACTIBQuantity: 30 mg in 1 1

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT