FDA.reportPublic FDA data

Application 202121

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROGESTERONEPROGESTERONECAPSULE;ORAL100MGNoNo
002PROGESTERONEPROGESTERONECAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5353ProgesteroneProgesteroneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5353ProgesteroneProgesteroneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5354ProgesteroneProgesteroneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5354ProgesteroneProgesteroneTeva Pharmaceuticals USA, Inc.ANDACurrent
71335-0713ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-0713ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44578ORIG2013-06-04
24101SUPPL2013-06-04
44579SUPPL2012-10-15
24100ORIG2012-10-15
43386ORIG2012-10-09
22871SUPPL2012-10-09