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FDA Approval

LILETTA

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

FDA Approval Summary

Company
Allergan, Inc.
DUNS: 144796497
Effective Date
June 29, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Levonorgestrel(52 mg in 1 1)

Products1

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

LILETTA

Product Details

NDC Product Code
0023-5858
Application Number
NDA206229
Marketing Category
NDA (C73594)
Route of Administration
INTRAUTERINE
Effective Date
October 3, 2023
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
BARIUM SULFATEInactive
Code: 25BB7EKE2EClass: IACT
Code: 5W7SIA7YZWClass: ACTIBQuantity: 52 mg in 1 1
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