Application 202019
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VARENICLINE | VARENICLINE | TABLET; ORAL | 0.5MG | No | No |
| 002 | VARENICLINE | VARENICLINE | TABLET; ORAL | 1MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202019-001 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | 2024-02-28 | ||
| A202019-002 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | 2024-02-28 |
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 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | 2024-02-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | 2024-02-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | 2024-02-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2024-02-28 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | 6a51e52b5d6a… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202019-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | 2024-02-28 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202019-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2024-02-28 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202019-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202019-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202019-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202019-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202019-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202019-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202019-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202019-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202019-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202019-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202019-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202019-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202019-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202019-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202019-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202019-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202019-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202019-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202019-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202019-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202019-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202019-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202019-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202019-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202019-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202019-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202019-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202019-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202019-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202019-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202019-002 | AB | 1 | 6a51e52b5d6a… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202019-002 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| varenicline | VARENICLINE TARTRATE | A-S Medication Solutions | 6351047a-9896-4a30-8e49-4d306ce9c9c0 | 2024-06-14 | Warnings, Adverse reactions | varenicline |
| varenicline | VARENICLINE TARTRATE | A-S Medication Solutions | 2d5dfa6e-e69d-414a-8ff2-44714debbbe2 | 2024-04-29 | Warnings, Adverse reactions | varenicline |
| VARENICLINE | VARENICLINE | Bryant Ranch Prepack | e3cc710d-23d8-4d68-b854-b6f5f4e737fc | 2024-04-02 | Warnings, Adverse reactions | VARENICLINE VARENICLINE |
| Varenicline | VARENICLINE | Zydus Pharmaceuticals USA Inc. | 1d4c9535-f185-4ea3-9140-60c4bb77f736 | 2024-02-10 | Warnings, Adverse reactions | Varenicline VARENICLINE |
| varenicline | VARENICLINE TARTRATE | Major Pharmaceuticals | 1297c291-da28-4a73-9c28-d5adee36d7b7 | 2023-12-15 | Warnings, Adverse reactions | varenicline |
| Varenicline | VARENICLINE TARTRATE | Camber Pharmaceuticals, Inc. | 7bd1abc8-2689-496b-b3f2-1cefe218ff5a | 2023-11-08 | Warnings, Adverse reactions | Varenicline |
| Varenicline | VARENICLINE | Zydus Lifesciences Limited | 481b94af-ee34-44be-8ca1-b2415525efac | 2023-09-28 | Varenicline VARENICLINE | |
| VARENICLINE | VARENICLINE | A-S Medication Solutions | 99414eca-c601-431c-8e84-2066b2e8221c | 2023-04-30 | Warnings, Adverse reactions | VARENICLINE VARENICLINE |
| VARENICLINE | VARENICLINE | A-S Medication Solutions | 92bc4c24-6c4f-4acf-b747-e3ef0cab1297 | 2023-04-25 | Warnings, Adverse reactions | VARENICLINE VARENICLINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.