FDA.reportPublic FDA data

Application 210441

Type
ANDA
Sponsor
APPCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL200MGNoNo
002HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL100MGNoNo
003HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL300MGNoNo
004HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7046HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEMajor PharmaceuticalsANDACurrent
0904-7046HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEMajor PharmaceuticalsANDACurrent
0904-7046HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEMajor PharmaceuticalsANDACurrent
43598-131HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-131HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-132HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-132HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-133HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-133HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
43598-721HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEDr. Reddy's Laboratories Inc.ANDACurrent
50268-412HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEAvPAKANDACurrent
50268-412HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEAvPAKANDACurrent
55154-3567HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATECardinal Health 107, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62506ORIG2020-04-08
62505ORIG2020-04-08