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| BENTYL | DICYCLOMINE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | |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| BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 |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| 2026-08 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | 84e616aacf4f… | |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| 2026-08 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | 84e616aacf4f… | |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| 2026-07 | N007409-001 | BENTYL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-10-15 | caaa826d4ba7… | |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| 2026-07 | N007409-003 | BENTYL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-10-15 | caaa826d4ba7… | |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 | Chartwell RX, LLC | d628ac1c-404d-45eb-8aab-0e550c95ed4a | 2024-10-10 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 82832a91-d16c-3a63-e053-2a91aa0a3ffb | 2024-09-12 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 20ef2c05-d0a4-405c-e063-6394a90ae697 | 2024-08-30 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | American Health Packaging | 833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8 | 2024-08-29 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 07361f0e-90c7-4531-8d3f-1ec5e7fed40d | 2024-08-23 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | a16e7b6b-dbc9-463d-9bde-dba4f25589cf | 2024-08-23 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 40e21575-320f-2ac6-e054-00144ff88e88 | 2024-08-14 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 4ae8d2fd-a7fb-4cc4-a2cb-720c5a2e2022 | 2024-08-12 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 600f3b80-0303-4f2d-929b-edb689b5b357 | 2024-07-30 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1e0260d0-aaad-aa9f-e063-6294a90a531a | 2024-07-24 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | 350ce812-b9a7-401a-9793-55d2e14bb760 | 2024-07-18 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7c75f650-c97d-06fa-e053-2991aa0a43bb | 2024-07-18 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 51742add-363d-3f9d-e054-00144ff8d46c | 2024-07-09 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 517646d8-366e-5cf2-e054-00144ff88e88 | 2024-07-08 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1b420733-b3b7-e504-e063-6394a90abba7 | 2024-06-19 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bionpharma Inc. | 051bfee3-06cf-309a-e063-6394a90a0bb3 | 2024-05-23 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 26a94263-46c0-4938-849c-ffb396e48dd3 | 2024-04-09 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Actavis Pharma, Inc. | a5937c7b-cdfc-46e6-a0fa-541b24f91d47 | 2024-04-01 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | A-S Medication Solutions | b3c9dc85-2c6c-44f0-9c98-02673af934cb | 2024-02-09 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 226a3a6e-9419-448a-827f-01199b792762 | 2024-02-06 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.