FDA.reportPublic FDA data

Application 206456

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-4839Oxycodone HydrochlorideOxycodone HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-4839Oxycodone HydrochlorideOxycodone HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-4839Oxycodone HydrochlorideOxycodone HydrochloridePharmaceutical Associates, Inc.ANDACurrent
60432-706Oxycodone Hydrochlorideoxycodone hydrochlorideMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-706Oxycodone Hydrochlorideoxycodone hydrochlorideMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-706Oxycodone Hydrochlorideoxycodone hydrochlorideMorton Grove Pharmaceuticals, Inc.ANDACurrent
67296-1324Oxycodone HydrochlorideOxycodone HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1324Oxycodone HydrochlorideOxycodone HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1324Oxycodone HydrochlorideOxycodone HydrochlorideRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76213ORIG 2023-11-03
32809ORIG2015-06-18