Application 218985
- Type
- ANDA
- Sponsor
- UMEDICA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No |
| 002 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218985-001 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2026-01-09 | |
| A218985-002 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2026-01-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218985-001 | AB |
| A218985-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218985-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2026-01-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218985-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2026-01-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218985-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2026-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218985-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2026-01-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218985-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2026-01-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218985-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2026-01-09 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218985-001 | VARENICLINE TARTRATE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2026-01-09 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218985-002 | VARENICLINE TARTRATE | EQ 1MG BASE | TABLET / ORAL | AB | 2026-01-09 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218985-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218985-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218985-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218985-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218985-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218985-002 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218985-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218985-002 | 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 | 2d5dfa6e-e69d-414a-8ff2-44714debbbe2 | 2024-04-29 | Warnings, Adverse reactions | VARENICLINE TARTRATE |
| varenicline | VARENICLINE TARTRATE | Major Pharmaceuticals | 1297c291-da28-4a73-9c28-d5adee36d7b7 | 2023-12-15 | Warnings, Adverse reactions | VARENICLINE TARTRATE |
| Varenicline | VARENICLINE TARTRATE | Camber Pharmaceuticals, Inc. | 7bd1abc8-2689-496b-b3f2-1cefe218ff5a | 2023-11-08 | Warnings, Adverse reactions | VARENICLINE TARTRATE |
| CHANTIX | VARENICLINE TARTRATE | Proficient Rx LP | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | VARENICLINE TARTRATE |
| CHANTIX | VARENICLINE TARTRATE | Proficient Rx LP | f22e3aef-714b-4014-8d77-83ee03fd1f57 | 2020-01-01 | Warnings, Adverse reactions | VARENICLINE TARTRATE |
| CHANTIX | VARENICLINE TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | b4403cea-6300-4d89-8fde-5149a80b08b9 | 2017-12-18 | Warnings, Adverse reactions | VARENICLINE TARTRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.