Application 209063
- Type
- ANDA
- Sponsor
- BRECKENRIDGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIVASTIGMINE | RIVASTIGMINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 4.6MG/24HR | No | No |
| 002 | RIVASTIGMINE | RIVASTIGMINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 9.5MG/24HR | No | No |
| 003 | RIVASTIGMINE | RIVASTIGMINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 13.3MG/24HR | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209063-001 | RIVASTIGMINE | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | |
| A209063-002 | RIVASTIGMINE | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | |
| A209063-003 | RIVASTIGMINE | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209063-001 | AB |
| A209063-002 | AB |
| A209063-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209063-002 | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209063-003 | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209063-001 | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2019-11-26 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209063-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209063-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209063-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209063-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209063-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209063-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209063-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209063-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209063-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209063-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209063-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209063-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209063-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209063-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209063-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209063-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209063-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209063-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209063-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209063-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209063-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209063-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209063-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209063-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209063-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209063-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209063-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209063-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209063-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209063-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209063-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209063-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209063-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209063-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209063-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209063-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209063-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209063-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209063-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209063-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|
| 51991-897 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-897 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-897 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-898 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-898 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-898 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-899 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-899 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-899 | Rivastigmine Transdermal System | Rivastigmine | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 63629-2064 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2064 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2064 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2064 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2065 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2065 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2065 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2065 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2065 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2066 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2066 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2066 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2066 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8807 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8807 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8807 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8807 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8807 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8807 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8846 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8846 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8846 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8846 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8846 | Rivastigmine Transdermal System | Rivastigmine | Bryant Ranch Prepack | ANDA | Current |
| 72855-100 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |
| 72855-100 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |
| 72855-100 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |
| 72855-101 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |
| 72855-101 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |
| 72855-101 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |
| 72855-102 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |
| 72855-102 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |
| 72855-102 | Rivastigmine Transdermal System | Rivastigmine | Adhexpharma | ANDA | Current |