FDA.reportPublic FDA data

Application 060704

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

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
0440-8505Tetracycline HydrochlorideTetracycline HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
10544-590Tetracycline HydrochlorideTetracycline HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-302Tetracycline HydrochlorideTetracycline HydrochlorideRebel Distributors CorpANDACurrent
21695-640Tetracycline HydrochlorideTetracycline HydrochlorideRebel Distributors CorpANDACurrent
52959-336Tetracycline HydrochlorideTetracycline HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
63629-1501Tetracycline HydrochlorideTetracycline HydrochlorideBryant Ranch PrepackANDACurrent
67046-728Tetracycline HydrochlorideTetracycline HydrochlorideContract Pharmacy Services-PAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18303SUPPL2014-01-31