Application 020793

Type
NDA
Sponsor
HIKMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CAFCITCAFFEINE CITRATESOLUTION;INTRAVENOUSEQ 30MG BASE/3ML (EQ 10MG BASE/ML)YesYes
002CAFCITCAFFEINE CITRATESOLUTION;ORALEQ 30MG BASE/3ML (EQ 10MG BASE/ML)YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6164CAFCITcaffeine citrateWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6164CAFCITcaffeine citrateHikma Pharmaceuticals USA Inc.NDACurrent

Documents

DocumentSubmission typeDate
62031SUPPL2020-03-04
62025SUPPL2020-03-04
35383SUPPL2015-12-22
25855SUPPL2010-06-16
20964ORIG2005-07-15
3381SUPPL2002-02-08
3380SUPPL2002-01-18
35382SUPPL2000-04-12
25854SUPPL2000-04-12
35381ORIG1999-09-21
3379ORIG1999-09-21