Application 007409
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENTYL | DICYCLOMINE HYDROCHLORIDE | TABLET;ORAL | 20MG | Yes | No |
| 003 | BENTYL | DICYCLOMINE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N007409-001 | BENTYL | DICYCLOMINE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | |
| N007409-003 | BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 |
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| 2026-08 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N007409-001 | BENTYL | 20MG | TABLET / ORAL | RLD | 1984-10-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N007409-003 | BENTYL | 10MG | CAPSULE / ORAL | RLD | 1984-10-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N007409-001 | BENTYL | 20MG | TABLET / ORAL | RLD | 1984-10-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N007409-003 | BENTYL | 10MG | CAPSULE / ORAL | RLD | 1984-10-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N007409-001 | BENTYL | 20MG | TABLET / ORAL | AB | RLD, RS | 1984-10-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N007409-003 | BENTYL | 10MG | CAPSULE / ORAL | AB | RLD, RS | 1984-10-15 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N007409-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N007409-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N007409-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N007409-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N007409-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N007409-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N007409-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N007409-003 | AB | 1 | ea99ee380514… |
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 | NuCare Pharmaceuticals,Inc. | 0d07a460-5cb1-cd4b-e063-6294a90a291d | 2024-02-05 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c77ef2f7-a846-5e05-e053-2995a90aaae0 | 2024-01-22 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | b3b8ee01-ec7c-4b17-a237-59ba45cdf3f9 | 2023-10-26 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Solco Healthcare US,LLC | d0954a7a-812b-487e-8c22-2a2a58303277 | 2023-07-28 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 01413a77-48f8-1a8a-e063-6394a90ae494 | 2023-07-24 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Proficient Rx LP | 346bbb6a-3499-4e90-af22-95f1cd0c0417 | 2023-07-01 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 99d7d1ce-47b5-4bbd-afe0-908505a9a51b | 2023-06-05 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Aurobindo Pharma Limited | ec746016-eed0-4e37-bb9c-cb430c8a7f07 | 2023-05-19 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Aurobindo Pharma Limited | d81b93f8-bebc-455e-82b6-9a3de3f82e92 | 2023-05-04 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | A-S Medication Solutions | 5f5d7145-118b-4cab-bfe0-19f7740ef1fe | 2023-02-04 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | aa5bd79d-7f18-4032-8862-0c5429b2ecaf | 2023-01-31 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Proficient Rx LP | bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876 | 2022-03-01 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine | DICYCLOMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 5a553bda-1e3d-4b80-913f-73dd54655033 | 2021-11-30 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Novitium Pharma LLC | b0911994-0b36-439d-8247-5d885a899421 | 2021-04-23 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | American Regent, Inc. | cab4ecaf-8895-4ae8-add3-233d9cc570a8 | 2021-03-01 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | Fosun Pharma USA Inc. | cbc22f25-e100-4c59-8f38-5f82113166fb | 2019-10-19 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 860e8ea6-6f9b-4fe6-a23d-3600b69c0b35 | 2019-04-29 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | da2c43f8-1c3a-447f-8994-f9899fb5e141 | 2018-12-20 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.