FDA.reportPublic FDA data

Application 212796

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
43598-486Nicotine PolacrilexNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-486Nicotine PolacrilexNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-486Nicotine PolacrilexNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-487Nicotine PolacrilexNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-487Nicotine PolacrilexNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-487Nicotine PolacrilexNicotine PolacrilexDr. Reddy's Laboratories Inc.ANDACurrent
43598-986HabitrolNicotine Polacrilex Lozenge 2 mgDr. Reddy's Laboratories Inc.ANDACurrent
43598-987HabitrolNicotine Polacrilex Lozenge 4 mgDr. Reddy's Laboratories Inc.ANDACurrent
63868-732Nicotine Polacrilex Lozenge MintNicotine Polacrilex Lozenge 4 mgChain Drug Marketing Association INCANDACurrent
63868-733Nicotine Polacrilex Lozenge MintNicotine Polacrilex Lozenge 2 mgChain Drug Marketing Association INCANDACurrent
68071-2722Nicotine PolacrilexNicotine PolacrilexNuCare Pharmaceuticals,Inc.ANDACurrent