FDA.reportPublic FDA data

Application 213233

Type
ANDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINE POLACRILEXNICOTINE POLACRILEXTROCHE/LOZENGE;ORALEQ 2MG BASENoNo
002NICOTINE POLACRILEXNICOTINE POLACRILEXTROCHE/LOZENGE;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-488Nicotine PolacrilexNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-489Nicotine PolacrilexNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-984Habitrol LozengeNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-984Habitrol LozengeNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-985Habitrol LozengeNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-985Habitrol LozengeNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent