FDA.reportPublic FDA data

Application 021690

Type
NDA
Sponsor
ORTHO MCNEIL PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTHO TRI-CYCLEN 21ETHINYL ESTRADIOL; NORGESTIMATETABLET; ORAL-210.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MGNoNo
002ORTHO TRI-CYCLEN 28ETHINYL ESTRADIOL; NORGESTIMATETABLET; ORAL-280.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
15996SUPPL2015-05-04
5995SUPPL2015-05-04
42272ORIG2007-08-22
28389ORIG2005-05-17
23074ORIG2005-05-13
15995ORIG2005-05-13
52092ORIG1900-01-01
52091ORIG1900-01-01
52090ORIG1900-01-01
52089ORIG1900-01-01
52088ORIG1900-01-01
52087ORIG1900-01-01