FDA.reportPublic FDA data

Application 040161

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1227DicyclomineDicyclomine hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1227DicyclomineDicyclomine hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1227DicyclomineDicyclomine HydrochlorideWest-ward Pharmaceutical CorpANDACurrent
0143-1227DicyclomineDicyclomine hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0615-1516DicyclomineDicyclomine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-597DicyclomineDicyclomine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
50090-5454DicyclomineDicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5454DicyclomineDicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5454DicyclomineDicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
52959-221DicyclomineDicyclomine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
53808-0899DicyclomineDicyclomine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
55700-933DicyclomineDicyclomine hydrochlorideQuality Care Products, LLCANDACurrent
67296-1741DicyclomineDicyclomine hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1741DicyclomineDicyclomine hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1741DicyclomineDicyclomine hydrochlorideRedPharm Drug, Inc.ANDACurrent
68788-9934DicyclomineDicyclomine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
70934-518DicyclomineDicyclomine hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent