Application 212694
- Type
- ANDA
- Sponsor
- QUAGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | TABLET;ORAL | 0.5MG | No | No |
| 002 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | TABLET;ORAL | 1MG | No | No |
| 003 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212694-001 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2025-02-11 | |
| A212694-002 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2025-02-11 | |
| A212694-003 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2025-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212694-001 | AA |
| A212694-002 | AA |
| A212694-003 | AA |
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 | A212694-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2025-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212694-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2025-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212694-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2025-02-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212694-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2025-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212694-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2025-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212694-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2025-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212694-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2025-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212694-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2025-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212694-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2025-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212694-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2025-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212694-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2025-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212694-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2025-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212694-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2025-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212694-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2025-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212694-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2025-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212694-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2025-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212694-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2025-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212694-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2025-02-11 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212694-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2025-02-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212694-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2025-02-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212694-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2025-02-11 | 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 | A212694-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212694-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212694-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212694-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212694-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212694-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212694-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212694-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212694-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212694-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212694-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212694-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212694-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212694-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212694-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212694-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212694-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212694-003 | AA | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212694-001 | AA | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212694-002 | AA | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212694-003 | AA | 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 |
|---|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | ae749a71-d253-474d-a26c-bec780c5b09c | 2026-02-16 | Warnings, Adverse reactions | 212694 ANDA212694 |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | 9270d14c-b885-4679-8871-6f2547450398 | 2026-01-07 | Warnings, Adverse reactions | 212694 ANDA212694 |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | 284e78af-7544-4c4a-8081-74e45501dc76 | 2026-01-07 | Warnings, Adverse reactions | 212694 ANDA212694 |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | QUAGEN PHARMACEUTICALS LLC | e1f0a249-e660-4592-9ffc-1c02b1022778 | 2025-06-17 | Warnings, Adverse reactions | 212694 ANDA212694 |