FDA.reportPublic FDA data

Application 040317

Type
ANDA
Sponsor
MYLAN

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
0378-1620Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
50090-2186Dicyclomine Hydrochloridedicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
50090-2186Dicyclomine Hydrochloridedicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
50090-3080Dicyclomine Hydrochloridedicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
51079-119Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-119Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-119Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Institutional Inc.ANDACurrent
55154-5684Dicyclomine HydrochlorideDicyclomine HydrochlorideCardinal HealthANDACurrent
55700-372Dicyclomine Hydrochloridedicyclomine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
67296-1304Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1304Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68788-9291Dicyclomine Hydrochloridedicyclomine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9291Dicyclomine Hydrochloridedicyclomine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9291Dicyclomine Hydrochloridedicyclomine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9291Dicyclomine Hydrochloridedicyclomine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0236Dicyclomine Hydrochloridedicyclomine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0236Dicyclomine Hydrochloridedicyclomine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0236Dicyclomine Hydrochloridedicyclomine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0236Dicyclomine Hydrochloridedicyclomine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0858Dicyclomine Hydrochloridedicyclomine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0858Dicyclomine Hydrochloridedicyclomine hydrochlorideREMEDYREPACK INC.ANDACurrent
71610-118Dicyclomine Hydrochloridedicyclomine hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7622ORIG1999-09-07