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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020076-004HABITROLNICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-005HABITROLNICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-006HABITROLNICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-121e350fbaab3a…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Transdermal System Patch Step 3NICOTINE TRANSDERMAL SYSTEM PATCHBluePoint Laboratories4856e99a-badc-b957-e063-6294a90a86062026-07-10WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine Transdermal System step 3NICOTINEAmerisourceBergen Drug Corporatione51d2c09-a20f-eb9b-e3e4-013f3e488ab32026-07-01WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINERugby Laboratoriesae406389-0f83-d5c8-bd2f-56075e57453a2026-03-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 0536-1106
ndc (product): 0536-1108
ndc (product): 0536-1107
Nicotine Transdermal System step 3NICOTINECARDINAL HEALTH 110, LLC. DBA LEADERdbbed17b-8ad3-05fb-fb63-03fbb75eae052026-03-18WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
NICOTINE TRANSDERMAL SYSTEMNICOTINEA-S Medication Solutionscfb56e3e-ac5d-4086-a5d3-23080844b3e12026-03-13WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEGolden State Medical Supply, Inc.7c83d507-7e8d-496c-bb9d-63abfa25c7a72025-04-17WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINECVS Pharmacyd51d5224-f5bf-2510-1fa0-c4bb454f81602024-12-01WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEStrategic Sourcing Services LLC6c0b5b5c-cc76-6e48-c364-4db0e081557d2024-11-09WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINERite Aid Corporationd2e32434-ec58-943e-dbeb-8e73315315952024-07-26WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 11822-4974
ndc (product): 11822-4975
ndc (product): 11822-4973
NICOTINE TRANSDERMALNICOTINERite Aid Corporationae6027da-5c96-ed47-e1ae-e900fc0f72ce2024-07-26WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 11822-3627
Nicotine transdermal system step 3NICOTINEThe Kroger Co.13cdd780-4196-685b-3cab-f9694a3276182024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 59450-002
ndc (product): 59450-003
ndc (product): 59450-001
Habitrol Step 3NICOTINE TRANSDERMAL SYSTEM PATCHDr. Reddy's Laboratories Inc.051be7ae-6504-c2d8-7424-2e328e4fcfc22024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 55741-446
ndc (product): 55741-448
ndc (product): 55741-447
Nicotine transdermal system step 2NICOTINEChain Drug Marketing Association INCdf1348cb-0d15-7e4b-921c-d8764c858e662024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal systemNICOTINEDr. Reddys Laboratories Inc.e2391b29-9bac-fc09-f2a5-a3370bc4e2c32024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 43598-445
nicotine transdermal systemNICOTINEDr. Reddy's Laboratories Inc.b9946e3c-80c9-3076-7c32-e2988ac070482024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 55741-449
Nicotine transdermal system step 1NICOTINEDOLGENCORP, LLC81e55db2-897e-e567-5743-63179783291a2024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 55910-313
Nicotine transdermal system step 3NICOTINEWalgreens Companyde471db4-b332-0490-198d-d354802728742024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 0363-0455
ndc (product): 0363-0457
ndc (product): 0363-0451
Nicotine transdermal system step 3NICOTINEDr. Reddy's Laboratories Inc.3a68eb70-0548-fa6f-8b1c-375e8799f24f2024-07-24WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 43598-447
ndc (product): 43598-448
ndc (product): 43598-446
Nicotine transdermal system step 3NICOTINEA-S Medication Solutions798a66fa-25d8-4713-b25f-56875431e37d2023-03-02WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 112 matching rows.

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