FDA.reportPublic FDA data

Application 020076

Type
NDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HABITROLNICOTINEFilm, Extended Release; Transdermal7MG/24HRNoNo
002HABITROLNICOTINEFilm, Extended Release; Transdermal14MG/24HRNoNo
003HABITROLNICOTINEFilm, Extended Release; Transdermal21MG/24HRNoNo
004HABITROLNICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL7MG/24HRYesNo
005HABITROLNICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL14MG/24HRYesNo
006HABITROLNICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL21MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-6011Meijer NICOTINE TRANSDERMAL SYSTEMNICOTINENovartis Consumer HealthNDACurrent
0067-6012Meijer NICOTINE TRANSDERMAL SYSTEMNICOTINENovartis Consumer HealthNDACurrent
0067-6013Meijer NICOTINE TRANSDERMAL SYSTEMNICOTINENovartis Consumer HealthNDACurrent
0363-0451NicotineNicotineWalgreens CompanyNDACurrent
0363-0451NICOTINENICOTINEWalgreens CompanyNDACurrent
0363-0451NICOTINENICOTINEWalgreens CompanyNDACurrent
0363-0455NicotineNicotineWalgreens CompanyNDACurrent
0363-0455NICOTINENICOTINEWalgreens CompanyNDACurrent
0363-0455NICOTINENICOTINEWalgreens CompanyNDACurrent
0363-0457NicotineNicotineWalgreens CompanyNDACurrent
0363-0457NICOTINENICOTINEWalgreens CompanyNDACurrent
0363-0457NICOTINENICOTINEWalgreens CompanyNDACurrent
0536-1106NICOTINENICOTINERugby LaboratoriesNDACurrent
0536-1106NicotineNicotineRugby LaboratoriesNDACurrent
0536-1106NICOTINENICOTINERugby LaboratoriesNDACurrent
0536-1107NICOTINENICOTINERugby LaboratoriesNDACurrent
0536-1107NicotineNicotineRugby LaboratoriesNDACurrent
0536-1107NICOTINENICOTINERugby LaboratoriesNDACurrent
0536-1108NICOTINENICOTINERugby LaboratoriesNDACurrent
0536-1108NicotineNicotineRugby LaboratoriesNDACurrent
0536-1108NICOTINENICOTINERugby LaboratoriesNDACurrent
11822-3627NICOTINENICOTINERite Aid CorporationNDACurrent
11822-3627NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4973NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4973NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4973NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4974NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4974NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4974NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4975NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4975NICOTINENICOTINERite Aid CorporationNDACurrent
11822-4975NICOTINENICOTINERite Aid CorporationNDACurrent
37205-358LEADER NICOTINE TRANSDERMAL SYSTEMNICOTINECardinal HealthNDACurrent
37205-361LEADER NICOTINE TRANSDERMAL SYSTEMNICOTINECardinal HealthNDACurrent
37205-363LEADER NICOTINE TRANSDERMAL SYSTEMNICOTINECardinal HealthNDACurrent
43598-445NicotineNicotineDr. Reddy's Laboratories Inc.NDACurrent
43598-445NICOTINENICOTINEDr. Reddy's Laboratories LimitedNDACurrent
43598-445NICOTINENICOTINEDr. Reddy's Laboratories Inc.NDACurrent
43598-446NicotineNicotineDr. Reddy's Laboratories Inc.NDACurrent
43598-446NICOTINENICOTINEDr. Reddy's Laboratories Inc.NDACurrent
43598-447NicotineNicotineDr. Reddy's Laboratories Inc.NDACurrent
43598-447NICOTINENICOTINEDr. Reddy's Laboratories Inc.NDACurrent
43598-448NicotineNicotineDr. Reddy's Laboratories Inc.NDACurrent
43598-448NICOTINENICOTINEDr. Reddy's Laboratories Inc.NDACurrent
49035-782NicotineNicotineWal-mart Stores IncNDACurrent
49035-782NICOTINENICOTINEWal-mart Stores IncNDACurrent
49348-144NICOTINENICOTINEMckesson (Sun Mark)NDACurrent
49348-144NICOTINENICOTINEStrategic Sourcing Services LLCNDACurrent
49348-145NICOTINENICOTINEMckesson (Sun Mark)NDACurrent
49348-145NICOTINENICOTINEStrategic Sourcing Services LLCNDACurrent
49348-146NICOTINENICOTINEMckesson (Sun Mark)NDACurrent
49348-146NICOTINENICOTINEStrategic Sourcing Services LLCNDACurrent
49781-142NICOTINENICOTINECardinal Health (Leader)NDACurrent
49781-143NICOTINENICOTINECardinal Health (Leader)NDACurrent
49781-144NICOTINENICOTINECardinal Health (Leader)NDACurrent
50090-1972NICOTINENICOTINEA-S Medication SolutionsNDACurrent
50090-1972NICOTINENICOTINEA-S Medication SolutionsNDACurrent
50090-2837NICOTINENICOTINEA-S Medication SolutionsNDACurrent
50090-2860NICOTINENICOTINEA-S Medication SolutionsNDACurrent
50090-2860NICOTINENICOTINEA-S Medication SolutionsNDACurrent
50090-2860NICOTINENICOTINEA-S Medication SolutionsNDACurrent
50090-2955NICOTINENICOTINEA-S Medication SolutionsNDACurrent
50090-3008NICOTINENICOTINEA-S Medication SolutionsNDACurrent
55741-446HabitrolNicotine Transdermal System PatchDr. Reddy's Laboratories Inc.NDACurrent
55741-446HabitrolNicotine Transdermal System PatchDr. Reddy's Laboratories Inc.NDACurrent
55741-447HabitrolNicotine Transdermal System PatchDr. Reddy's Laboratories Inc.NDACurrent
55741-447HabitrolNicotine Transdermal System PatchDr. Reddy's Laboratories Inc.NDACurrent
55741-448HabitrolNicotine Transdermal System PatchDr. Reddy's Laboratories Inc.NDACurrent
55741-448HabitrolNicotine Transdermal System PatchDr. Reddy's Laboratories Inc.NDACurrent
55741-449NICOTINENICOTINEDr. Reddy's Laboratories Inc.NDACurrent
55910-313NicotineNicotineDOLGENCORP, LLCNDACurrent
55910-313NICOTINENICOTINEDOLGENCORP, LLCNDACurrent
59450-001NICOTINENICOTINEThe Kroger Co.NDACurrent
59450-001NicotineNicotineThe Kroger Co.NDACurrent
59450-001NICOTINENICOTINEThe Kroger Co.NDACurrent
59450-002NICOTINENICOTINEThe Kroger Co.NDACurrent
59450-002NicotineNicotineThe Kroger Co.NDACurrent
59450-002NICOTINENICOTINEThe Kroger Co.NDACurrent
59450-003NICOTINENICOTINEThe Kroger Co.NDACurrent
59450-003NicotineNicotineThe Kroger Co.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57115SUPPL2019-02-01
57116SUPPL2019-01-04
54863SUPPL2018-07-06
54847SUPPL2018-07-06
49085SUPPL2017-07-26
49081SUPPL2017-07-25
12185SUPPL2016-07-18
12184SUPPL2016-07-08
21119SUPPL2016-07-07
1993SUPPL2016-07-07
12183SUPPL2016-06-17
21118SUPPL2016-05-16
12182SUPPL2014-07-29
21117SUPPL2014-07-28
21116SUPPL2006-05-16
1992SUPPL2005-11-30
21115SUPPL2004-10-29
21113SUPPL2004-03-03
21114SUPPL2004-01-22
21112SUPPL2002-07-15
12181SUPPL2002-07-15
34239SUPPL2002-07-12
1991SUPPL2002-07-12
21111SUPPL1999-11-12