Application 021641
- Type
- NDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZILECT | RASAGILINE MESYLATE | TABLET;ORAL | EQ 0.5MG BASE | Yes | No |
| 002 | AZILECT | RASAGILINE MESYLATE | TABLET;ORAL | EQ 1MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021641-001 | AZILECT | RASAGILINE MESYLATE | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 |
| N021641-002 | AZILECT | RASAGILINE MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021641-001 | AB |
| N021641-002 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021641-001 | 7572834 | 2026-12-05 | Drug product | ||
| N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 |
| N021641-002 | 7572834 | 2026-12-05 | Drug product | ||
| N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product |
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 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021641-001 | AZILECT | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-16 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021641-002 | AZILECT | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-16 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021641-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021641-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021641-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021641-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021641-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021641-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021641-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021641-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021641-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021641-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021641-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021641-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021641-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021641-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021641-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021641-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021641-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021641-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021641-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021641-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021641-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021641-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021641-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021641-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021641-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021641-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021641-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021641-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021641-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021641-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021641-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021641-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021641-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021641-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021641-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021641-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021641-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021641-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021641-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021641-002 | AB | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021641-001 | 7572834 | 2026-12-05 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021641-002 | 7572834 | 2026-12-05 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021641-001 | 7572834 | 2026-12-05 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021641-002 | 7572834 | 2026-12-05 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021641-001 | 7572834 | 2026-12-05 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021641-002 | 7572834 | 2026-12-05 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021641-001 | 7572834 | 2026-12-05 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021641-002 | 7572834 | 2026-12-05 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021641-001 | 7572834 | 2026-12-05 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021641-002 | 7572834 | 2026-12-05 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021641-001 | 7572834 | 2026-12-05 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021641-002 | 7572834 | 2026-12-05 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021641-001 | 7572834 | 2026-12-05 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021641-002 | 7572834 | 2026-12-05 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021641-001 | 7572834 | 2026-12-05 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021641-002 | 7572834 | 2026-12-05 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021641-001 | 7572834 | 2026-12-05 | Drug product | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021641-002 | 7572834 | 2026-12-05 | Drug product | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021641-001 | 7572834 | 2026-12-05 | Drug product | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021641-001 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | 2010-11-08 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021641-002 | 7572834 | 2026-12-05 | Drug product | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021641-002 | 7815942 | 2027-08-27 | U-219 | Drug substance, Drug product | d06236e962d9… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Rasagiline | RASAGILINE | Teva Pharmaceuticals USA, Inc. | e802c83c-e581-4a11-b83d-1df47120078d | 2020-06-30 | Warnings, Adverse reactions | 021641 NDA021641 0093-3060 0093-3061 |
| Azilect | RASAGILINE MESYLATE | Teva Neuroscience, Inc. | a40d0e73-3f9f-4b01-979d-402c9cdaeb60 | 2020-06-30 | Warnings, Adverse reactions | 021641 NDA021641 68546-142 68546-229 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-3060 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3060 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3060 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3060 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3060 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3060 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3060 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3060 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3061 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3061 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3061 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3061 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3061 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3061 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3061 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3061 | Rasagiline | Rasagiline | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 42291-779 | Rasagiline | Rasagiline | AvKARE | NDA AUTHORIZED GENERIC | Current |
| 42291-779 | Rasagiline | Rasagiline | AvKARE | NDA AUTHORIZED GENERIC | Current |
| 42291-780 | Rasagiline | Rasagiline | AvKARE | NDA AUTHORIZED GENERIC | Current |
| 42291-780 | Rasagiline | Rasagiline | AvKARE | NDA AUTHORIZED GENERIC | Current |
| 43353-015 | Azilect | Rasagiline Mesylate | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 68546-142 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-142 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-142 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-142 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-142 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-142 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-142 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-229 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-229 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-229 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-229 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-229 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-229 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-229 | Azilect | Rasagiline mesylate | Teva Neuroscience, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63599 | SUPPL | 2020-06-17 |
| 63593 | SUPPL | 2020-06-17 |
| 56979 | SUPPL | 2018-12-21 |
| 5904 | SUPPL | 2014-06-02 |
| 5903 | SUPPL | 2014-06-02 |
| 37386 | SUPPL | 2014-05-30 |
| 15913 | SUPPL | 2014-05-30 |
| 28298 | SUPPL | 2010-01-26 |
| 28297 | SUPPL | 2010-01-26 |
| 28296 | SUPPL | 2010-01-26 |
| 28295 | SUPPL | 2010-01-26 |
| 28294 | SUPPL | 2010-01-26 |
| 5902 | SUPPL | 2010-01-26 |
| 5901 | SUPPL | 2010-01-26 |
| 42246 | SUPPL | 2010-01-22 |
| 24207 | SUPPL | 2010-01-22 |
| 37385 | SUPPL | 2009-12-10 |
| 37384 | SUPPL | 2009-12-10 |
| 37383 | SUPPL | 2009-12-10 |
| 37382 | SUPPL | 2009-12-10 |
| 15912 | SUPPL | 2009-12-10 |
| 15911 | SUPPL | 2009-12-10 |
| 15910 | SUPPL | 2009-12-10 |
| 21765 | ORIG | 2006-07-24 |
| 5900 | ORIG | 2006-05-21 |
| 37381 | ORIG | 2006-05-18 |