Application 216736
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 002 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216736-001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | |
| A216736-002 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 40MG | TABLET / ORAL | RS | 2025-03-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216736-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216736-002 | DICYCLOMINE HYDROCHLORIDE | 40MG | TABLET / ORAL | RS | 2025-03-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216736-002 | DICYCLOMINE HYDROCHLORIDE | 40MG | TABLET / ORAL | RS | 2025-03-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216736-002 | DICYCLOMINE HYDROCHLORIDE | 40MG | TABLET / ORAL | RS | 2025-03-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216736-002 | DICYCLOMINE HYDROCHLORIDE | 40MG | TABLET / ORAL | RS | 2025-03-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | 3bdfa0b2c4d7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216736-001 | DICYCLOMINE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2022-12-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216736-002 | DICYCLOMINE HYDROCHLORIDE | 40MG | TABLET / ORAL | RS | 2025-03-25 | 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 | A216736-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A216736-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216736-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216736-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216736-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216736-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216736-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216736-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216736-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216736-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216736-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216736-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216736-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216736-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216736-001 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216736-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A216736-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A216736-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216736-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216736-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216736-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216736-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A216736-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A216736-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216736-001 | 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 |
|---|---|---|---|---|---|---|
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 41aed1c9-b32f-3694-e063-6394a90a29e4 | 2026-06-25 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 3c1e31d4-c8b5-459e-9ada-2f1bae7fa219 | 2026-02-26 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Advagen Pharma Ltd., | b4331e24-58af-45fb-a25b-9eb8270f83f7 | 2026-02-23 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | c0a6db32-1061-4721-b5ea-0082ff41acbf | 2026-01-06 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Northwind Health Company, LLC | 1d9acff5-6e8c-58dd-e063-6394a90a38f2 | 2026-01-01 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Redpharm Drug | 3b0ae3ed-77ef-d0df-e063-6294a90a7d17 | 2025-12-25 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Redpharm Drug | 3de47f8d-e265-3f40-e063-6394a90aa3b0 | 2025-12-02 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | A-S Medication Solutions | 3713ae82-f36d-4491-9978-3111599ceafb | 2025-11-01 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 1f3f4e0e-c04d-4208-8549-2bacaf547176 | 2025-10-22 | Warnings, Adverse reactions | 216736 ANDA216736 |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Trifluent Pharma, LLC | 56282794-5874-4220-b25c-cea4b17d19aa | 2025-09-30 | Warnings, Adverse reactions | 216736 ANDA216736 |