FDA.reportPublic FDA data

Application 204910

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PARICALCITOLPARICALCITOLSOLUTION;INTRAVENOUS0.002MG/ML (0.002MG/ML)NoNo
002PARICALCITOLPARICALCITOLSOLUTION;INTRAVENOUS0.005MG/ML (0.005MG/ML)NoNo
003PARICALCITOLPARICALCITOLSOLUTION;INTRAVENOUS0.01MG/2ML (0.005MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-562ParicalcitolParicalcitolDr. Reddy's Laboratories IncANDACurrent
43598-562ParicalcitolParicalcitolDr. Reddy's Laboratories, Inc.ANDACurrent
43598-563ParicalcitolParicalcitolDr. Reddy's Laboratories IncANDACurrent
43598-563ParicalcitolParicalcitolDr. Reddy's Laboratories, Inc.ANDACurrent
43598-564ParicalcitolParicalcitolDr. Reddy's Laboratories IncANDACurrent
43598-564ParicalcitolParicalcitolDr. Reddy's Laboratories, Inc.ANDACurrent
43598-565ParicalcitolParicalcitolDr. Reddy's Laboratories IncANDACurrent
43598-565ParicalcitolParicalcitolDr. Reddy's Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45149ORIG2016-08-17