MedPath
FDA Approval

Ortho Tri Cyclen

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

FDA Approval Summary

Company
Effective Date
February 27, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Manufacturing Establishments1

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

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products1

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

Ortho Tri Cyclen

Product Details

NDC Product Code
54868-4093
Application Number
NDA021690
Marketing Category
NDA (C73594)
Effective Date
February 27, 2012
© Copyright 2025. All Rights Reserved by MedPath