FDA.reportPublic FDA data

Application 200936

Type
ANDA
Sponsor
TOLMAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMGEL;TOPICAL3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1483Diclofenac SodiumDiclofenac SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1483Diclofenac SodiumDiclofenac SodiumImpax GenericsANDACurrent
0115-1483Diclofenac SodiumDiclofenac SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1483Diclofenac SodiumDiclofenac SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1483Diclofenac SodiumDiclofenac SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1483Diclofenac SodiumDiclofenac SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
55700-588Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-588Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
70518-0851Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
76420-025Diclofenac SodiumDiclofenac SodiumAsclemed USA, Inc.ANDACurrent
80425-0234Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58924ORIG2019-06-03
18986ORIG2013-11-19
9854ORIG2013-10-29