Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Atlantic Biologicals Corps
047437707
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Atlantic Biologicals Corps
Atlantic Biologicals Corps
Atlantic Biologicals Corps
047437707
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Creon
Product Details
NDC Product Code
17856-1212Application Number
NDA020725Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 27, 2012Pancrelipase lipaseActive
Code: 8MYC33932OClass: ACTIBQuantity: 12000 [USP'U] in 1 1
cetyl alcoholInactive
Code: 936JST6JCNClass: IACT
Pancrelipase amylaseActive
Code: YOJ58O116EClass: ACTIBQuantity: 60000 [USP'U] in 1 1
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
Pancrelipase proteaseActive
Code: 3560D81V50Class: ACTIBQuantity: 38000 [USP'U] in 1 1
dimethiconeInactive
Code: 92RU3N3Y1OClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT