Application 040721
- Type
- ANDA
- Sponsor
- IMPAX LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | TABLET;ORAL | 25MG | No | No |
| 004 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040721-001 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | ||
| A040721-002 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | ||
| A040721-003 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | ||
| A040721-004 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040721-001 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2006-11-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040721-002 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2006-11-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040721-003 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2006-11-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040721-004 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2006-11-01 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Amneal Pharmaceuticals of New York LLC | 16523451-cd3d-4c10-be06-d59a6f12ac68 | 2026-01-29 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 11ba3d38-a61b-4b03-ba03-4ccf2e450d1f | 2025-10-27 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | American Health Packaging | da12a817-9f34-4f26-a7dc-e0e8f9be91c3 | 2024-12-02 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Amneal Pharmaceuticals LLC | 45285692-de51-413e-8a51-7fb792eccc81 | 2024-10-23 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Chartwell RX, LLC | 89267333-ba8b-455b-a8dc-515a888463c2 | 2024-01-22 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.