FDA.reportPublic FDA data

Application 089903

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEINJECTABLE;INJECTIONEQ 5MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-0491Prochlorperazine EdisylateProchlorperazine EdisylateBaxter Healthcare CorporationANDACurrent
0641-6135Prochlorperazine EdisylateProchlorperazine EdisylateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6135Prochlorperazine EdisylateProchlorperazine EdisylateWest-Ward Pharmaceuticals Corp.ANDACurrent
51662-1558PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
72572-580Prochlorperazine EdisylateProchlorperazine EdisylateCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53905ORIG2018-05-01
39606SUPPL2013-01-09