FDA.reportPublic FDA data

Application 211776

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFLUPREDNATEDIFLUPREDNATEEMULSION;OPHTHALMIC0.05%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-341DIFLUPREDNATEDIFLUPREDNATECipla USA Inc.ANDACurrent
76282-708DIFLUPREDNATEDIFLUPREDNATEExelan Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68521ORIG2021-09-02