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FDA Approval

Ella

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

FDA Approval Summary

Company
Effective Date
March 1, 2021
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.

A-S Medication Solutions

A-S Medication Solutions

830016429

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
50090-2835
Application Number
NDA022474
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
May 10, 2018
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: YF7V70N02BClass: ACTIBQuantity: 30 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
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