FDA.reportPublic FDA data

Application 040319

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1610Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1610Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1610Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
50090-2184Dicyclomine Hydrochloridedicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
50090-2185Dicyclomine Hydrochloridedicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
50090-2185Dicyclomine Hydrochloridedicyclomine hydrochlorideA-S Medication SolutionsANDACurrent
51079-118Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-118Dicyclomine Hydrochloridedicyclomine hydrochlorideMylan Institutional Inc.ANDACurrent
52959-168DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEH.J. Harkins Company inc.ANDACurrent
53808-0644Dicyclomine Hydrochloridedicyclomine hydrochlorideState of Florida DOH Central PharmacyANDACurrent
55154-5599Dicyclomine HydrochlorideDicyclomine HydrochlorideCardinal HealthANDACurrent
55700-359Dicyclomine Hydrochloridedicyclomine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
63629-6320Dicyclomine Hydrochloridedicyclomine hydrochlorideBryant Ranch PrepackANDACurrent
63629-6320Dicyclomine Hydrochloridedicyclomine hydrochlorideBryant Ranch PrepackANDACurrent
68151-2265Dicyclomine Hydrochloridedicyclomine hydrochlorideCarilion Materials ManagementANDACurrent
68788-7059Dicyclomine Hydrochloridedicyclomine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7948Dicyclomine Hydrochloridedicyclomine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71205-043Dicyclomine Hydrochloridedicyclomine hydrochlorideProficient Rx LPANDACurrent
71205-043Dicyclomine Hydrochloridedicyclomine hydrochlorideProficient Rx LPANDACurrent
71335-0588Dicyclomine Hydrochloridedicyclomine hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29924ORIG1999-09-07