Manufacturing Establishments9
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ortho Pharmaceutical Division of Janssen Ortho, LLC
Physicians Total Care, Inc.
084894661
Janssen Ortho LLC
Physicians Total Care, Inc.
062191882
Ortho Biologics LLC a division of OMJ Pharmaceutical, Inc.
Physicians Total Care, Inc.
606111821
NV Organon
Physicians Total Care, Inc.
402157499
Gedeon Richter Plc
Physicians Total Care, Inc.
401140279
Ortho-McNeil-Janssen Pharmaceuticals, Inc, Ortho-McNeil Unit
Physicians Total Care, Inc.
010779978
Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Physicians Total Care, Inc.
063137772
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Sanofi Chimie
Physicians Total Care, Inc.
291538267
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ORTHO TRI CYCLEN Lo
Product Details
NDC Product Code
54868-4730Application Number
NDA021241Marketing Category
NDA (C73594)Effective Date
August 8, 2011