Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RPK Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
147096275
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ella
Product Details
NDC Product Code
53002-2630Application Number
NDA022474Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 11, 2020CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
UlipristalActive
Code: YF7V70N02BClass: ACTIBQuantity: 30 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT