Application 020076
- Type
- NDA
- Sponsor
- DR REDDYS LABS SA
Application Products#
| 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 |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020076-005 | HABITROL | 14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020076-006 | HABITROL | 21MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1999-11-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020076-004 | HABITROL | 7MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1999-11-12 | 1e350fbaab3a… |
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.
NDC Listings For This Application#
| 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57115 | SUPPL | 2019-02-01 |
| 57116 | SUPPL | 2019-01-04 |
| 54863 | SUPPL | 2018-07-06 |
| 54847 | SUPPL | 2018-07-06 |
| 49085 | SUPPL | 2017-07-26 |
| 49081 | SUPPL | 2017-07-25 |
| 12185 | SUPPL | 2016-07-18 |
| 12184 | SUPPL | 2016-07-08 |
| 21119 | SUPPL | 2016-07-07 |
| 1993 | SUPPL | 2016-07-07 |
| 12183 | SUPPL | 2016-06-17 |
| 21118 | SUPPL | 2016-05-16 |
| 12182 | SUPPL | 2014-07-29 |
| 21117 | SUPPL | 2014-07-28 |
| 21116 | SUPPL | 2006-05-16 |
| 1992 | SUPPL | 2005-11-30 |
| 21115 | SUPPL | 2004-10-29 |
| 21113 | SUPPL | 2004-03-03 |
| 21114 | SUPPL | 2004-01-22 |
| 21112 | SUPPL | 2002-07-15 |
| 12181 | SUPPL | 2002-07-15 |
| 34239 | SUPPL | 2002-07-12 |
| 1991 | SUPPL | 2002-07-12 |
| 21111 | SUPPL | 1999-11-12 |