FDA.reportPublic FDA data

Application 083677

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL20MGNoNo
002PREDNISONEPREDNISONETABLET;ORAL5MGNoNo
003PREDNISONEPREDNISONETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9738PrednisonePrednisoneWest-ward Pharmaceuticals CorpANDACurrent
0143-9738PrednisonePrednisoneWest-ward Pharmaceuticals CorpANDACurrent
0143-9738PrednisonePrednisoneWest-ward PharmaceuticalsANDACurrent
0378-0642PrednisonePrednisoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0642PrednisonePrednisoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0642PrednisonePrednisoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0642PrednisonePrednisoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0642PrednisonePrednisoneMylan Pharmaceuticals IncANDACurrent
0440-8167PrednisonePrednisoneLiberty Pharmaceuticals, Inc.ANDACurrent
10544-473PrednisonePrednisoneBlenheim Pharmacal, Inc.ANDACurrent
10544-509PrednisonePrednisoneBlenheim Pharmacal, Inc.ANDACurrent
12634-188PrednisonePrednisoneApotheca Inc.ANDACurrent
21695-307PrednisonePrednisoneRebel Distributors CorpANDACurrent
50090-0099PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-0100PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-0101PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50436-4326PrednisonePrednisoneUnit Dose ServicesANDACurrent
53217-288PrednisonePrednisoneAidarex Pharmaceuticals LLCANDACurrent
53808-0399PrednisonePREDNISONEState of Florida DOH Central PharmacyANDACurrent
59115-141PrednisonePrednisoneHikma PharmaceuticalANDACurrent
61919-342PREDNISONEPREDNISONEDirectRXANDACurrent
61919-342PrednisonePrednisoneDIRECT RXANDACurrent
61919-342PREDNISONEPREDNISONEDirect_RxANDACurrent
61919-342PREDNISONEPREDNISONEDirect_RxANDACurrent
63187-085PrednisonePrednisoneProficient Rx LPANDACurrent
63187-085PrednisonePrednisoneProficient Rx LPANDACurrent
67296-0974PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
67296-0974PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
67296-0974PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
68387-240PrednisonePREDNISONEKeltman Pharmaceuticals Inc.ANDACurrent
68387-241PrednisonePREDNISONEKeltman Pharmaceuticals Inc.ANDACurrent
69668-120DeltasonePrednisoneOculus Innovative SciencesANDACurrent
70518-0205PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-0800PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-0800PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent