FDA.reportPublic FDA data

Application 209269

Type
NDA
Sponsor
EPI HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOLIRAMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 105MG BASENoNo
002MINOLIRAMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 135MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-539MinoliraMinoliraDr. Reddys Laboratories IncNDACurrent
43598-540MinoliraMinoliraDr. Reddys Laboratories IncNDACurrent
71403-101Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-101Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-101Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-101Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-102Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-102Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-102Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-102Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54737ORIG2018-07-02