FDA.reportPublic FDA data

Application 040362

Type
ANDA
Sponsor
JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL10MGNoNo
002PREDNISONEPREDNISONETABLET;ORAL5MGNoNo
003PREDNISONEPREDNISONETABLET;ORAL20MGNoNo
004PREDNISONEPREDNISONETABLET;ORAL2.5MGNoNo
005PREDNISONEPREDNISONETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7127PrednisonePrednisoneMajor PharmaceuticalsANDACurrent
10544-913PrednisonePrednisoneBlenheim Pharmacal, Inc.ANDACurrent
10544-914PrednisonePrednisoneBlenheim Pharmacal, Inc.ANDACurrent
10544-915PrednisonePrednisoneBlenheim Pharmacal, Inc.ANDACurrent
42291-727PrednisonePrednisoneAvKAREANDACurrent
42291-727PrednisonePrednisoneAvKAREANDACurrent
43063-703PrednisonePrednisonePD-Rx Pharmaceuticals, InANDACurrent
43063-703PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-703PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-703PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-703PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-703PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-703PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-866PrednisonePrednisonePD-Rx Pharmaceuticals, InANDACurrent
43063-866PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-866PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-866PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-866PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-866PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-866PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-911PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-911PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-911PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-911PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-911PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-911PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-911PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
48433-321PrednisonePrednisoneSafecor Health, LLCANDACurrent
50090-3137PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3137PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3137PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3137PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3330PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3330PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3330PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3335PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3335PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3336PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3336PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3336PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3354PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3354PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3361PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3361PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3361PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3361PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-4428PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-5202PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50436-1720PrednisonePrednisoneUnit Dose ServicesANDACurrent
50436-1720PrednisonePrednisoneUnit Dose ServicesANDACurrent
50436-1730PrednisonePrednisoneUnit Dose ServicesANDACurrent
50436-1730PrednisonePrednisoneUnit Dose ServicesANDACurrent
50436-1750PrednisonePrednisoneUnit Dose ServicesANDACurrent
50436-1750PrednisonePrednisoneUnit Dose ServicesANDACurrent
51655-208PrednisonePrednisoneNORTHWIND PHARMACEUTICALSANDACurrent
53002-3090PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-3090PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-3091PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-3091PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-3250PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-3250PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53217-255PrednisonePrednisoneAidarex Pharmaceuticals LLCANDACurrent
53217-292PrednisonePrednisoneAidarex Pharmaceuticals LLCANDACurrent
53217-336PrednisonePrednisoneAidarex Pharmaceuticals LLCANDACurrent
55700-203PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-203PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-203PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-203PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-203PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-203PrednisonePrednisoneLake Erie Medical DBA QuaANDACurrent
55700-208PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-208PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-208PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-208PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-208PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-208PrednisonePrednisoneLake Erie Medical DBA QuaANDACurrent
55700-209PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-209PrednisonePrednisoneLake Erie Medical DBA QuaANDACurrent
55700-209PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-209PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29940ORIG2001-08-29