FDA.reportPublic FDA data

Application 065131

Type
ANDA
Sponsor
PAR PHARM

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 BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-589MinocyclineMinocyclineAvKAREANDACurrent
42291-589MinocyclineMinocyclineAvKARE, Inc.ANDACurrent
42291-589MinocyclineMinocyclineAvKAREANDACurrent
42291-589MinocyclineMinocyclineAvKAREANDACurrent
42291-591MinocyclineMinocyclineAvKARE, Inc.ANDACurrent
42291-591MinocyclineMinocyclineAvKAREANDACurrent
42291-591MinocyclineMinocyclineAvKAREANDACurrent
42291-591MinocyclineMinocyclineAvKAREANDACurrent
49884-096DYNACINMinocycline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-097DYNACINMinocycline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-098DYNACINMinocycline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-511MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-511MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-511MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-511MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-512MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-512MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-512MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-512MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-513MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-513MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-513MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
49884-513MinocyclineMinocyclinePar Pharmaceutical, Inc.ANDACurrent
63629-2228MinocyclineMinocyclineBryant Ranch PrepackANDACurrent
63629-2228MinocyclineMinocyclineBryant Ranch PrepackANDACurrent
63629-2229MinocyclineMinocyclineBryant Ranch PrepackANDACurrent
63629-2229MinocyclineMinocyclineBryant Ranch PrepackANDACurrent
64380-154Minocycline HydrochlorideMinocycline HydrochlorideStrides Pharma Science LimitedANDACurrent
64380-154Minocycline HydrochlorideMinocycline HydrochlorideStrides Pharma Science LimitedANDACurrent
64380-155Minocycline HydrochlorideMinocycline HydrochlorideStrides Pharma Science LimitedANDACurrent
64380-155Minocycline HydrochlorideMinocycline HydrochlorideStrides Pharma Science LimitedANDACurrent
64380-156Minocycline HydrochlorideMinocycline HydrochlorideStrides Pharma Science LimitedANDACurrent
64380-156Minocycline HydrochlorideMinocycline HydrochlorideStrides Pharma Science LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18330SUPPL2014-03-04