FDA.reportPublic FDA data

Application 063065

Type
ANDA
Sponsor
WATSON LABS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-3153Minocycline HydrochlorideMinocycline HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3153Minocycline HydrochlorideMinocycline HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5695Minocycline HydrochlorideMinocycline HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5695Minocycline HydrochlorideMinocycline HydrochlorideActavis Pharma, Inc.ANDACurrent
43353-105Minocycline HydrochlorideMinocycline HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
49999-505Minocycline HydrochlorideMinocycline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0635Minocycline HydrochlorideMinocycline HydrochlorideA-S Medication SolutionsANDACurrent
55289-201Minocycline HydrochlorideMinocycline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-201Minocycline HydrochlorideMinocycline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-201Minocycline HydrochlorideMinocycline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-201Minocycline HydrochlorideMinocycline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-201Minocycline HydrochlorideMinocycline HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
66336-377Minocycline HydrochlorideMinocycline HydrochlorideDispensing Solution, Inc.ANDACurrent
67296-1181Minocycline HydrochlorideMinocycline HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1181Minocycline HydrochlorideMinocycline HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1181Minocycline HydrochlorideMinocycline HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-4216Minocycline HydrochlorideMinocycline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4216Minocycline HydrochlorideMinocycline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4227Minocycline HydrochlorideMinocycline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68151-2299Minocycline HydrochlorideMinocycline HydrochlorideCarilion Materials ManagementANDACurrent
71335-1045Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39404SUPPL2004-06-09
18317SUPPL2004-06-09
42777SUPPL2003-08-27
22292SUPPL2003-08-27
22291ORIG2003-07-24
30617SUPPL1999-06-10
8348SUPPL1999-06-10