FDA.reportPublic FDA data

Application 062031

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECAPSULE;ORALEQ 100MG BASENoNo
002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECAPSULE;ORALEQ 50MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-5440Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5440Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5440Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5535Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5535Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5535Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
33261-899Doxycycline HyclateDoxycycline HyclateAidarex Pharmaceuticals LLCANDACurrent
51655-184Doxycycline HyclateDoxycycline HyclateNorthwind PharmaceuticalsANDACurrent
53808-0962Doxycycline HyclateDoxycycline HyclateState of Florida DOH Central PharmacyANDACurrent
55154-2650Doxycycline HyclateDoxycycline HyclateCardinal HealthANDACurrent
60687-118Doxycycline HyclateDoxycycline HyclateAmerican Health PackagingANDACurrent
60687-118Doxycycline HyclateDoxycycline HyclateAmerican Health PackagingANDACurrent
60687-118Doxycycline HyclateDoxycycline HyclateAmerican Health PackagingANDACurrent
64725-5440Doxycycline HyclateDoxycycline HyclateTYA PharmaceuticalsANDACurrent
71335-0635Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent