Application 207975
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANTRELA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 15MG | Yes | No |
| 002 | VANTRELA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 003 | VANTRELA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 45MG | Yes | No |
| 004 | VANTRELA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | Yes | No |
| 005 | VANTRELA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 90MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N207975-001 | VANTRELA ER | HYDROCODONE BITARTRATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | |
| N207975-002 | VANTRELA ER | HYDROCODONE BITARTRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | |
| N207975-003 | VANTRELA ER | HYDROCODONE BITARTRATE | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | |
| N207975-004 | VANTRELA ER | HYDROCODONE BITARTRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | |
| N207975-005 | VANTRELA ER | HYDROCODONE BITARTRATE | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N207975-001 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | |
| N207975-001 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | |
| N207975-001 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | |
| N207975-002 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | |
| N207975-002 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | |
| N207975-002 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | |
| N207975-003 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | |
| N207975-003 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | |
| N207975-003 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | |
| N207975-004 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | |
| N207975-004 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | |
| N207975-004 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | |
| N207975-005 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | |
| N207975-005 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | |
| N207975-005 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N207975-001 | VANTRELA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-002 | VANTRELA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-003 | VANTRELA ER | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-004 | VANTRELA ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-005 | VANTRELA ER | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-001 | VANTRELA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-002 | VANTRELA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-003 | VANTRELA ER | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-004 | VANTRELA ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-005 | VANTRELA ER | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-001 | VANTRELA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-002 | VANTRELA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-003 | VANTRELA ER | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-004 | VANTRELA ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-005 | VANTRELA ER | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207975-001 | VANTRELA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207975-002 | VANTRELA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207975-003 | VANTRELA ER | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207975-004 | VANTRELA ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207975-005 | VANTRELA ER | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207975-001 | VANTRELA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207975-002 | VANTRELA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207975-003 | VANTRELA ER | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207975-004 | VANTRELA ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207975-005 | VANTRELA ER | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207975-001 | VANTRELA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207975-002 | VANTRELA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207975-003 | VANTRELA ER | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207975-004 | VANTRELA ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207975-005 | VANTRELA ER | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207975-001 | VANTRELA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207975-002 | VANTRELA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207975-003 | VANTRELA ER | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207975-004 | VANTRELA ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207975-005 | VANTRELA ER | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207975-001 | VANTRELA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207975-002 | VANTRELA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207975-003 | VANTRELA ER | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207975-004 | VANTRELA ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207975-005 | VANTRELA ER | 90MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-17 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N207975-001 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-001 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-001 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-002 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-002 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-002 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-003 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-003 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-003 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-004 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-004 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-004 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-005 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-005 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207975-005 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-001 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-001 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-001 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-002 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-002 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-002 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-003 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-003 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-003 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-004 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-004 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-004 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-005 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-005 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207975-005 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-001 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-001 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-001 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-002 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-002 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-002 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-003 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-003 | 9572803 | 2027-09-13 | Drug product | 2017-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-003 | 8445018 | 2029-07-31 | Drug product | 2017-01-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207975-004 | 9216176 | 2027-09-13 | Drug product | 2017-01-19 | 011fe1cb6892… |
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 |
|---|---|---|---|---|---|---|
| Hysingla ER | HYDROCODONE BITARTRATE | Knoa Pharma LLC | b7d23ac2-e776-9f62-3290-c64c2d6eb353 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE |
| Hydrocodone Bitartrate | HYDROCODONE BITARTRATE | Alvogen Inc. | f7b55d14-0980-b680-8ceb-7489ff65455e | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE |
| Hydrocodone Bitartrate | HYDROCODONE BITARTRATE | Alvogen Inc. | a7b8ea07-e926-f0a5-c20d-92f23ed350d0 | 2023-12-19 | Boxed warning, Warnings, Adverse reactions | HYDROCODONE BITARTRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.