Application 208765

Type
ANDA
Sponsor
MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 75MG BASENoNo
002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 150MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-695Doxycycline HyclateDoxycycline HyclateMayne Pharma Inc.ANDACurrent
51862-695Doxycycline HyclateDoxycycline HyclateMayne Pharma Inc.ANDACurrent
51862-695Doxycycline HyclateDoxycycline HyclateMayne Pharma Inc.ANDACurrent
51862-696Doxycycline HyclateDoxycycline HyclateMayne Pharma Inc.ANDACurrent
51862-696Doxycycline HyclateDoxycycline HyclateMayne Pharma Inc.ANDACurrent
51862-696Doxycycline HyclateDoxycycline HyclateMayne Pharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48721ORIG2017-06-15