FDA.reportPublic FDA data

Application 080292

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9740PrednisonePrednisoneWest-ward Pharmaceuticals CorpANDACurrent
0143-9740PrednisonePrednisoneWest-ward PharmaceuticalsANDACurrent
0143-9740PrednisonePrednisoneWest-ward Pharmaceuticals CorpANDACurrent
0378-0640PrednisonePrednisoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0640PrednisonePrednisoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0640PrednisonePrednisoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0640PrednisonePrednisoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0640PrednisonePrednisoneMylan Pharmaceuticals IncANDACurrent
12634-184PrednisonePrednisoneApotheca Inc.ANDACurrent
21695-305PrednisonePrednisoneRebel Distributors CorpANDACurrent
42708-136PrednisonePrednisoneQPharma Inc.ANDACurrent
50090-0095PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-0096PrednisonePrednisoneA-S Medication SolutionsANDACurrent
59115-139PrednisonePrednisoneHikma PharmaceuticalANDACurrent
61919-373PrednisonePrednisoneDirect RxANDACurrent
61919-373PrednisonePrednisoneDirect RxANDACurrent
67296-1331PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent