FDA.reportPublic FDA data

Application 211041

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITISINONENITISINONECAPSULE;ORAL2MGNoNo
002NITISINONENITISINONECAPSULE;ORAL5MGNoNo
003NITISINONENITISINONECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0254-3020NitisinoneNitisinonePar Pharmaceutical, Inc.ANDACurrent
0254-3020NitisinoneNitisinonePar Pharmaceutical, Inc.ANDACurrent
0254-3021NitisinoneNitisinonePar Pharmaceutical, Inc.ANDACurrent
0254-3021NitisinoneNitisinonePar Pharmaceutical, Inc.ANDACurrent
0254-3022NitisinoneNitisinonePar Pharmaceutical, Inc.ANDACurrent
0254-3022NitisinoneNitisinonePar Pharmaceutical, Inc.ANDACurrent
63629-2233NitisinoneNitisinoneBryant Ranch PrepackANDACurrent
63629-2233NitisinoneNitisinoneBryant Ranch PrepackANDACurrent
63629-2234NitisinoneNitisinoneBryant Ranch PrepackANDACurrent
63629-2234NitisinoneNitisinoneBryant Ranch PrepackANDACurrent
63629-2235NitisinoneNitisinoneBryant Ranch PrepackANDACurrent
63629-2235NitisinoneNitisinoneBryant Ranch PrepackANDACurrent
70954-008NitisinoneNitisinoneNovitium Pharma LLCANDACurrent
70954-008NitisinoneNitisinoneNovitium Pharma LLCANDACurrent
70954-009NitisinoneNitisinoneNovitium Pharma LLCANDACurrent
70954-009NitisinoneNitisinoneNovitium Pharma LLCANDACurrent
70954-010NitisinoneNitisinoneNovitium Pharma LLCANDACurrent
70954-010NitisinoneNitisinoneNovitium Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60138ORIG2019-09-27