Home Applications 020076 Application 020076
Type NDA
Sponsor DR REDDYS LABS SA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HABITROL NICOTINE Film, Extended Release; Transdermal 7MG/24HR No No 002 HABITROL NICOTINE Film, Extended Release; Transdermal 14MG/24HR No No 003 HABITROL NICOTINE Film, Extended Release; Transdermal 21MG/24HR No No 004 HABITROL NICOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 7MG/24HR Yes No 005 HABITROL NICOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 14MG/24HR Yes No 006 HABITROL NICOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 21MG/24HR Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020076-004 HABITROL NICOTINE 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 N020076-005 HABITROL NICOTINE 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 N020076-006 HABITROL NICOTINE 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12
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 4 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N020076-004 HABITROL 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020076-005 HABITROL 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020076-006 HABITROL 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020076-004 HABITROL 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020076-005 HABITROL 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020076-006 HABITROL 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020076-004 HABITROL 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020076-005 HABITROL 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020076-006 HABITROL 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020076-004 HABITROL 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020076-005 HABITROL 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020076-006 HABITROL 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12 a50c72e98297…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 112 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0067-6011 Meijer NICOTINE TRANSDERMAL SYSTEM NICOTINE Novartis Consumer Health NDA Current 0067-6012 Meijer NICOTINE TRANSDERMAL SYSTEM NICOTINE Novartis Consumer Health NDA Current 0067-6013 Meijer NICOTINE TRANSDERMAL SYSTEM NICOTINE Novartis Consumer Health NDA Current 0363-0451 Nicotine Nicotine Walgreens Company NDA Current 0363-0451 NICOTINE NICOTINE Walgreens Company NDA Current 0363-0451 NICOTINE NICOTINE Walgreens Company NDA Current 0363-0455 Nicotine Nicotine Walgreens Company NDA Current 0363-0455 NICOTINE NICOTINE Walgreens Company NDA Current 0363-0455 NICOTINE NICOTINE Walgreens Company NDA Current 0363-0457 Nicotine Nicotine Walgreens Company NDA Current 0363-0457 NICOTINE NICOTINE Walgreens Company NDA Current 0363-0457 NICOTINE NICOTINE Walgreens Company NDA Current 0536-1106 NICOTINE NICOTINE Rugby Laboratories NDA Current 0536-1106 Nicotine Nicotine Rugby Laboratories NDA Current 0536-1106 NICOTINE NICOTINE Rugby Laboratories NDA Current 0536-1107 NICOTINE NICOTINE Rugby Laboratories NDA Current 0536-1107 Nicotine Nicotine Rugby Laboratories NDA Current 0536-1107 NICOTINE NICOTINE Rugby Laboratories NDA Current 0536-1108 NICOTINE NICOTINE Rugby Laboratories NDA Current 0536-1108 Nicotine Nicotine Rugby Laboratories NDA Current 0536-1108 NICOTINE NICOTINE Rugby Laboratories NDA Current 11822-3627 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-3627 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4973 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4973 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4973 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4974 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4974 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4974 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4975 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4975 NICOTINE NICOTINE Rite Aid Corporation NDA Current 11822-4975 NICOTINE NICOTINE Rite Aid Corporation NDA Current 37205-358 LEADER NICOTINE TRANSDERMAL SYSTEM NICOTINE Cardinal Health NDA Current 37205-361 LEADER NICOTINE TRANSDERMAL SYSTEM NICOTINE Cardinal Health NDA Current 37205-363 LEADER NICOTINE TRANSDERMAL SYSTEM NICOTINE Cardinal Health NDA Current 43598-445 Nicotine Nicotine Dr. Reddy's Laboratories Inc. NDA Current 43598-445 NICOTINE NICOTINE Dr. Reddy's Laboratories Limited NDA Current 43598-445 NICOTINE NICOTINE Dr. Reddy's Laboratories Inc. NDA Current 43598-446 Nicotine Nicotine Dr. Reddy's Laboratories Inc. NDA Current 43598-446 NICOTINE NICOTINE Dr. Reddy's Laboratories Inc. NDA Current 43598-447 Nicotine Nicotine Dr. Reddy's Laboratories Inc. NDA Current 43598-447 NICOTINE NICOTINE Dr. Reddy's Laboratories Inc. NDA Current 43598-448 Nicotine Nicotine Dr. Reddy's Laboratories Inc. NDA Current 43598-448 NICOTINE NICOTINE Dr. Reddy's Laboratories Inc. NDA Current 49035-782 Nicotine Nicotine Wal-mart Stores Inc NDA Current 49035-782 NICOTINE NICOTINE Wal-mart Stores Inc NDA Current 49348-144 NICOTINE NICOTINE Mckesson (Sun Mark) NDA Current 49348-144 NICOTINE NICOTINE Strategic Sourcing Services LLC NDA Current 49348-145 NICOTINE NICOTINE Mckesson (Sun Mark) NDA Current 49348-145 NICOTINE NICOTINE Strategic Sourcing Services LLC NDA Current 49348-146 NICOTINE NICOTINE Mckesson (Sun Mark) NDA Current 49348-146 NICOTINE NICOTINE Strategic Sourcing Services LLC NDA Current 49781-142 NICOTINE NICOTINE Cardinal Health (Leader) NDA Current 49781-143 NICOTINE NICOTINE Cardinal Health (Leader) NDA Current 49781-144 NICOTINE NICOTINE Cardinal Health (Leader) NDA Current 50090-1972 NICOTINE NICOTINE A-S Medication Solutions NDA Current 50090-1972 NICOTINE NICOTINE A-S Medication Solutions NDA Current 50090-2837 NICOTINE NICOTINE A-S Medication Solutions NDA Current 50090-2860 NICOTINE NICOTINE A-S Medication Solutions NDA Current 50090-2860 NICOTINE NICOTINE A-S Medication Solutions NDA Current 50090-2860 NICOTINE NICOTINE A-S Medication Solutions NDA Current 50090-2955 NICOTINE NICOTINE A-S Medication Solutions NDA Current 50090-3008 NICOTINE NICOTINE A-S Medication Solutions NDA Current 55741-446 Habitrol Nicotine Transdermal System Patch Dr. Reddy's Laboratories Inc. NDA Current 55741-446 Habitrol Nicotine Transdermal System Patch Dr. Reddy's Laboratories Inc. NDA Current 55741-447 Habitrol Nicotine Transdermal System Patch Dr. Reddy's Laboratories Inc. NDA Current 55741-447 Habitrol Nicotine Transdermal System Patch Dr. Reddy's Laboratories Inc. NDA Current 55741-448 Habitrol Nicotine Transdermal System Patch Dr. Reddy's Laboratories Inc. NDA Current 55741-448 Habitrol Nicotine Transdermal System Patch Dr. Reddy's Laboratories Inc. NDA Current 55741-449 NICOTINE NICOTINE Dr. Reddy's Laboratories Inc. NDA Current 55910-313 Nicotine Nicotine DOLGENCORP, LLC NDA Current 55910-313 NICOTINE NICOTINE DOLGENCORP, LLC NDA Current 59450-001 NICOTINE NICOTINE The Kroger Co. NDA Current 59450-001 Nicotine Nicotine The Kroger Co. NDA Current 59450-001 NICOTINE NICOTINE The Kroger Co. NDA Current 59450-002 NICOTINE NICOTINE The Kroger Co. NDA Current 59450-002 Nicotine Nicotine The Kroger Co. NDA Current 59450-002 NICOTINE NICOTINE The Kroger Co. NDA Current 59450-003 NICOTINE NICOTINE The Kroger Co. NDA Current 59450-003 Nicotine Nicotine The Kroger Co. NDA Current