FDA.reportPublic FDA data

Application 085223

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDETABLET;ORAL20MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideActavis Pharma, Inc.ANDACurrent
0615-7755Dicyclomine HydrochlorideDicyclomine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-081Dicyclomine HydrochlorideDicyclomine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-081Dicyclomine HydrochlorideDicyclomine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0130Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0130Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0130Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0130Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2863Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
51655-257Dicyclomine HydrochlorideDicyclomine HydrochlorideNorthwind PharmaceuticalsANDACurrent
53002-3450Dicyclomine HydrochlorideDicyclomine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3450Dicyclomine HydrochlorideDicyclomine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-324Dicyclomine HydrochlorideDicyclomine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53808-0234Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
58118-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideClinical Solutions WholesaleANDACurrent
58118-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideClinical Solutions WholesaleANDACurrent
58118-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideClinical Solutions WholesaleANDACurrent
60760-631Dicyclomine HydrochlorideDicyclomine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-795Dicyclomine HydrochlorideDicyclomine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-324DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-324DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-324DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEDIRECT RXANDACurrent
63187-784Dicyclomine HydrochlorideDicyclomine HydrochlorideProficient Rx LPANDACurrent
63187-784Dicyclomine HydrochlorideDicyclomine HydrochlorideProficient Rx LPANDACurrent
63187-784Dicyclomine HydrochlorideDicyclomine HydrochlorideProficient Rx LPANDACurrent
63629-6820Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6820Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
67046-118Dicyclomine HydrochlorideDicyclomine HydrochlorideContract Pharmacy Services-PAANDACurrent
67296-0126Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0126Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0126Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-1908Dicyclomine HydrochlorideDicyclomine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3255Dicyclomine HydrochlorideDicyclomine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3255Dicyclomine HydrochlorideDicyclomine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9525Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9525Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9525Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9525Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1596Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1596Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1596Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1596Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-682Dicyclomine HydrochlorideDicyclomine HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-682Dicyclomine HydrochlorideDicyclomine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0641Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0641Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0641Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
75921-795Dicyclomine HydrochlorideDicyclomine HydrochlorideLife Line Home Care Services, Inc.ANDACurrent