FDA.reportPublic FDA data

Application 065447

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDETABLET;ORAL150MGNoNo
002DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-625Demeclocycline HydrochlorideDemeclocycline HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-626Demeclocycline HydrochlorideDemeclocycline HydrochlorideMarlex Pharmaceuticals IncANDACurrent
24658-710Demeclocycline HydrochlorideDemeclocycline HydrochloridePuraCap Laboratories LLCANDACurrent
24658-711Demeclocycline HydrochlorideDemeclocycline HydrochloridePuraCap Laboratories LLCANDACurrent
42806-143Demeclocycline HydrochlorideDemeclocycline HydrochlorideEpic Pharma, LLCANDACurrent
42806-143Demeclocycline HydrochlorideDemeclocycline HydrochlorideEpic Pharma, LLCANDACurrent
42806-144Demeclocycline HydrochlorideDemeclocycline HydrochlorideEpic Pharma, LLCANDACurrent
42806-144Demeclocycline HydrochlorideDemeclocycline HydrochlorideEpic Pharma, LLCANDACurrent
60429-649Demeclocycline HydrochlorideDemeclocycline HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-649Demeclocycline HydrochlorideDemeclocycline HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-649Demeclocycline HydrochlorideDemeclocycline HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-663Demeclocycline HydrochlorideDemeclocycline HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-663Demeclocycline HydrochlorideDemeclocycline HydrochlorideGolden State Medical Supply, Inc.ACANDACurrent
60429-663Demeclocycline HydrochlorideDemeclocycline HydrochlorideGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30662ORIG2015-08-21