Application 021485
- Type
- NDA
- Sponsor
- ORION PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STALEVO 50 | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 12.5MG;200MG;50MG | Yes | Yes |
| 002 | STALEVO 100 | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 25MG;200MG;100MG | Yes | No |
| 003 | STALEVO 150 | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 37.5MG;200MG;150MG | Yes | No |
| 004 | STALEVO 200 | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 50MG;200MG;200MG | Yes | Yes |
| 005 | STALEVO 75 | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 18.75MG;200MG;75MG | Yes | No |
| 006 | STALEVO 125 | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 31.25MG;200MG;125MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021485-001 | STALEVO 50 | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET / ORAL | AB | RLD, RS | 2003-06-11 |
| N021485-002 | STALEVO 100 | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET / ORAL | AB | RLD | 2003-06-11 |
| N021485-003 | STALEVO 150 | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET / ORAL | AB | RLD | 2003-06-11 |
| N021485-004 | STALEVO 200 | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | TABLET / ORAL | AB | RLD, RS | 2007-08-02 |
| N021485-005 | STALEVO 75 | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | TABLET / ORAL | AB | RLD | 2008-08-29 |
| N021485-006 | STALEVO 125 | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | TABLET / ORAL | AB | RLD | 2008-08-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021485-001 | AB |
| N021485-002 | AB |
| N021485-003 | AB |
| N021485-004 | AB |
| N021485-005 | AB |
| N021485-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021485-001 | STALEVO 50 | 12.5MG;200MG;50MG | TABLET / ORAL | AB | RLD, RS | 2003-06-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-002 | STALEVO 100 | 25MG;200MG;100MG | TABLET / ORAL | AB | RLD | 2003-06-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-003 | STALEVO 150 | 37.5MG;200MG;150MG | TABLET / ORAL | AB | RLD | 2003-06-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-004 | STALEVO 200 | 50MG;200MG;200MG | TABLET / ORAL | AB | RLD, RS | 2007-08-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-005 | STALEVO 75 | 18.75MG;200MG;75MG | TABLET / ORAL | AB | RLD | 2008-08-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-006 | STALEVO 125 | 31.25MG;200MG;125MG | TABLET / ORAL | AB | RLD | 2008-08-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-001 | STALEVO 50 | 12.5MG;200MG;50MG | TABLET / ORAL | AB | RLD, RS | 2003-06-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-002 | STALEVO 100 | 25MG;200MG;100MG | TABLET / ORAL | AB | RLD | 2003-06-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-003 | STALEVO 150 | 37.5MG;200MG;150MG | TABLET / ORAL | AB | RLD | 2003-06-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-004 | STALEVO 200 | 50MG;200MG;200MG | TABLET / ORAL | AB | RLD, RS | 2007-08-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-005 | STALEVO 75 | 18.75MG;200MG;75MG | TABLET / ORAL | AB | RLD | 2008-08-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-006 | STALEVO 125 | 31.25MG;200MG;125MG | TABLET / ORAL | AB | RLD | 2008-08-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-001 | STALEVO 50 | 12.5MG;200MG;50MG | TABLET / ORAL | AB | RLD, RS | 2003-06-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-002 | STALEVO 100 | 25MG;200MG;100MG | TABLET / ORAL | AB | RLD | 2003-06-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-003 | STALEVO 150 | 37.5MG;200MG;150MG | TABLET / ORAL | AB | RLD | 2003-06-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-004 | STALEVO 200 | 50MG;200MG;200MG | TABLET / ORAL | AB | RLD, RS | 2007-08-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-005 | STALEVO 75 | 18.75MG;200MG;75MG | TABLET / ORAL | AB | RLD | 2008-08-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-006 | STALEVO 125 | 31.25MG;200MG;125MG | TABLET / ORAL | AB | RLD | 2008-08-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-001 | STALEVO 50 | 12.5MG;200MG;50MG | TABLET / ORAL | AB | RLD, RS | 2003-06-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-002 | STALEVO 100 | 25MG;200MG;100MG | TABLET / ORAL | AB | RLD | 2003-06-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-003 | STALEVO 150 | 37.5MG;200MG;150MG | TABLET / ORAL | AB | RLD | 2003-06-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-004 | STALEVO 200 | 50MG;200MG;200MG | TABLET / ORAL | AB | RLD, RS | 2007-08-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-005 | STALEVO 75 | 18.75MG;200MG;75MG | TABLET / ORAL | AB | RLD | 2008-08-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-006 | STALEVO 125 | 31.25MG;200MG;125MG | TABLET / ORAL | AB | RLD | 2008-08-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-001 | STALEVO 50 | 12.5MG;200MG;50MG | TABLET / ORAL | AB | RLD, RS | 2003-06-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-002 | STALEVO 100 | 25MG;200MG;100MG | TABLET / ORAL | AB | RLD | 2003-06-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-003 | STALEVO 150 | 37.5MG;200MG;150MG | TABLET / ORAL | AB | RLD | 2003-06-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-004 | STALEVO 200 | 50MG;200MG;200MG | TABLET / ORAL | AB | RLD, RS | 2007-08-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-005 | STALEVO 75 | 18.75MG;200MG;75MG | TABLET / ORAL | AB | RLD | 2008-08-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-006 | STALEVO 125 | 31.25MG;200MG;125MG | TABLET / ORAL | AB | RLD | 2008-08-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-001 | STALEVO 50 | 12.5MG;200MG;50MG | TABLET / ORAL | AB | RLD, RS | 2003-06-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-002 | STALEVO 100 | 25MG;200MG;100MG | TABLET / ORAL | AB | RLD | 2003-06-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-003 | STALEVO 150 | 37.5MG;200MG;150MG | TABLET / ORAL | AB | RLD | 2003-06-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-004 | STALEVO 200 | 50MG;200MG;200MG | TABLET / ORAL | AB | RLD, RS | 2007-08-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-005 | STALEVO 75 | 18.75MG;200MG;75MG | TABLET / ORAL | AB | RLD | 2008-08-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-006 | STALEVO 125 | 31.25MG;200MG;125MG | TABLET / ORAL | AB | RLD | 2008-08-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021485-001 | STALEVO 50 | 12.5MG;200MG;50MG | TABLET / ORAL | AB | RLD, RS | 2003-06-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021485-002 | STALEVO 100 | 25MG;200MG;100MG | TABLET / ORAL | AB | RLD | 2003-06-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021485-003 | STALEVO 150 | 37.5MG;200MG;150MG | TABLET / ORAL | AB | RLD | 2003-06-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021485-004 | STALEVO 200 | 50MG;200MG;200MG | TABLET / ORAL | AB | RLD, RS | 2007-08-02 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021485-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021485-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021485-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021485-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021485-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021485-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021485-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021485-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021485-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021485-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021485-004 | AB | 1 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021485-001 | 6500867 | 2020-06-29 | U-219 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021485-001 | 6797732 | 2020-06-29 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021485-002 | 6500867 | 2020-06-29 | U-219 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021485-002 | 6797732 | 2020-06-29 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021485-003 | 6500867 | 2020-06-29 | U-219 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021485-003 | 6797732 | 2020-06-29 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021485-004 | 6500867 | 2020-06-29 | U-219 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021485-004 | 6797732 | 2020-06-29 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021485-005 | 6500867 | 2020-06-29 | U-219 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021485-005 | 6797732 | 2020-06-29 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021485-006 | 6500867 | 2020-06-29 | U-219 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021485-006 | 6797732 | 2020-06-29 | Drug product | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021485-001 | 6500867 | 2020-06-29 | U-219 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021485-001 | 6797732 | 2020-06-29 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021485-002 | 6500867 | 2020-06-29 | U-219 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021485-002 | 6797732 | 2020-06-29 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021485-003 | 6500867 | 2020-06-29 | U-219 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021485-003 | 6797732 | 2020-06-29 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021485-004 | 6500867 | 2020-06-29 | U-219 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021485-004 | 6797732 | 2020-06-29 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021485-005 | 6500867 | 2020-06-29 | U-219 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021485-005 | 6797732 | 2020-06-29 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021485-006 | 6500867 | 2020-06-29 | U-219 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021485-006 | 6797732 | 2020-06-29 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021485-001 | 6500867 | 2020-06-29 | U-219 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021485-001 | 6797732 | 2020-06-29 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021485-002 | 6500867 | 2020-06-29 | U-219 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021485-002 | 6797732 | 2020-06-29 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021485-003 | 6500867 | 2020-06-29 | U-219 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021485-003 | 6797732 | 2020-06-29 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021485-004 | 6500867 | 2020-06-29 | U-219 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021485-004 | 6797732 | 2020-06-29 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021485-005 | 6500867 | 2020-06-29 | U-219 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021485-005 | 6797732 | 2020-06-29 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021485-006 | 6500867 | 2020-06-29 | U-219 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021485-006 | 6797732 | 2020-06-29 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021485-001 | 6500867 | 2020-06-29 | U-219 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021485-001 | 6797732 | 2020-06-29 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021485-002 | 6500867 | 2020-06-29 | U-219 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021485-002 | 6797732 | 2020-06-29 | Drug product | 3f01610625f2… |
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 |
|---|---|---|---|---|---|---|
| Carbidopa, Levodopa, and Entacapone | CARBIDOPA, LEVODOPA, AND ENTACAPONE | Sandoz Inc | 9c16c0e0-3b97-486b-b7d5-579f5853e2c5 | 2026-03-19 | Warnings, Adverse reactions | 021485 NDA021485 0781-5613 0781-5637 0781-5654 0781-5669 0781-5625 0781-5641 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0407 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0407 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0407 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0407 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0408 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0408 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0408 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0408 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0409 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0409 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0409 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0409 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0527 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0527 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0527 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0527 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0544 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0544 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0544 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0544 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0545 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0545 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0545 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0545 | Stalevo | carbidopa, levodopa, and entacapone | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0378-8300 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8301 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8302 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8302 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8302 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8303 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8303 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8303 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8304 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8304 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8305 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8305 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8305 | Carbidopa, Levodopa and Entacapone | carbidopa, levodopa and entacapone | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5613 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5613 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5625 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5625 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5637 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5637 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5641 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5641 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5654 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5654 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5669 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5669 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 47335-001 | Carbidopa, levodopa and entacapone | Carbidopa, levodopa and entacapone | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47335-002 | Carbidopa, levodopa and entacapone | Carbidopa, levodopa and entacapone | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47335-003 | Carbidopa, levodopa and entacapone | Carbidopa, levodopa and entacapone | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47335-004 | Carbidopa, levodopa and entacapone | Carbidopa, levodopa and entacapone | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47335-005 | Carbidopa, levodopa and entacapone | Carbidopa, levodopa and entacapone | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47335-006 | Carbidopa, levodopa and entacapone | Carbidopa, levodopa and entacapone | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 52427-805 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-805 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-805 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-809 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-809 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-809 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-816 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-816 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-816 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-827 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-827 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-827 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-834 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-834 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-834 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-842 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-842 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 52427-842 | Stalevo | carbidopa, levodopa, and entacapone | Almatica Pharma LLC | NDA | Current |
| 55648-782 | carbidopa, levodopa and entacapone | carbidopa, levodopa and entacapone | Wockhardt Limited | NDA AUTHORIZED GENERIC | Current |
| 55648-783 | carbidopa, levodopa and entacapone | carbidopa, levodopa and entacapone | Wockhardt Limited | NDA AUTHORIZED GENERIC | Current |
| 55648-784 | carbidopa, levodopa and entacapone | carbidopa, levodopa and entacapone | Wockhardt Limited | NDA AUTHORIZED GENERIC | Current |
| 55648-785 | carbidopa, levodopa and entacapone | carbidopa, levodopa and entacapone | Wockhardt Limited | NDA AUTHORIZED GENERIC | Current |
| 55648-786 | carbidopa, levodopa and entacapone | carbidopa, levodopa and entacapone | Wockhardt Limited | NDA AUTHORIZED GENERIC | Current |
| 55648-787 | carbidopa, levodopa and entacapone | carbidopa, levodopa and entacapone | Wockhardt Limited | NDA AUTHORIZED GENERIC | Current |
| 64679-782 | CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa, levodopa and entacapone | Wockhardt USA LLC. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85497 | SUPPL | 2026-03-24 |
| 85445 | SUPPL | 2026-03-23 |
| 61518 | SUPPL | 2020-01-06 |
| 61482 | SUPPL | 2019-12-31 |
| 55930 | SUPPL | 2018-10-15 |
| 55736 | SUPPL | 2018-10-01 |
| 15581 | SUPPL | 2016-02-25 |
| 5518 | SUPPL | 2016-02-24 |
| 15582 | SUPPL | 2016-02-23 |
| 27910 | SUPPL | 2014-07-24 |
| 5517 | SUPPL | 2014-07-24 |
| 37052 | SUPPL | 2014-07-23 |
| 37051 | SUPPL | 2014-07-23 |
| 5516 | SUPPL | 2010-10-13 |
| 15580 | SUPPL | 2010-10-11 |
| 44127 | ORIG | 2010-08-09 |
| 37048 | SUPPL | 2009-03-23 |
| 15578 | SUPPL | 2009-03-23 |
| 27907 | SUPPL | 2009-03-05 |
| 5512 | SUPPL | 2009-03-05 |
| 37047 | SUPPL | 2009-02-04 |
| 15577 | SUPPL | 2009-02-04 |
| 27908 | SUPPL | 2009-02-03 |
| 5513 | SUPPL | 2009-02-03 |
| 37050 | SUPPL | 2008-10-03 |
| 5515 | SUPPL | 2008-10-01 |
| 5514 | SUPPL | 2008-09-03 |
| 37049 | SUPPL | 2008-08-29 |
| 27909 | SUPPL | 2007-08-07 |
| 15579 | SUPPL | 2007-08-03 |
| 21686 | ORIG | 2004-03-24 |
| 15576 | ORIG | 2003-06-22 |
| 5511 | ORIG | 2003-06-22 |