MedPath
FDA Approval

Ella

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

FDA Approval Summary

Company
RedPharm Drug, Inc
DUNS: 828374897
Effective Date
February 15, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ulipristal(30 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

RedPharm Drug, Inc

RedPharm Drug, Inc

828374897

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
67296-1466
Application Number
NDA022474
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
February 15, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: YF7V70N02BClass: ACTIBQuantity: 30 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath