Application 208620

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONETESTOSTERONEGEL, METERED;TRANSDERMAL1.62% (20.25MG/1.25GM ACTUATION)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-304TestosteroneTestosteroneDr. Reddy's Laboratories, Inc.ANDACurrent
43598-304TestosteroneTestosteroneDr. Reddy's Laboratories, Inc.ANDACurrent
43598-304TestosteroneTestosteroneDr. Reddy's Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57747ORIG2019-02-21
55932ORIG2018-10-15
55491ORIG2018-09-14
54159ORIG2018-05-11
50992ORIG2018-01-08