Application 213662

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 75MG BASENoNo
003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59651-337Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-337Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-338Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-338Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-339Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-339Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent