FDA.reportPublic FDA data

Application 210662

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDECAPSULE;ORAL250MGNoNo
002TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDECAPSULE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-906Tetracycline HydrochlorideTetracycline HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-906Tetracycline HydrochlorideTetracycline HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-906Tetracycline HydrochlorideTetracycline HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-907Tetracycline HydrochlorideTetracycline HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-907Tetracycline HydrochlorideTetracycline HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-907Tetracycline HydrochlorideTetracycline HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
71335-2141Tetracycline HydrochlorideTetracycline HydrochlorideBryant Ranch PrepackANDACurrent