Application 085447
- Type
- ANDA
- Sponsor
- ABBOTT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | A-POXIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | CAPSULE;ORAL | 5MG | No | No |
| 002 | A-POXIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | No | No |
| 003 | A-POXIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085447-001 | A-POXIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | ||
| A085447-002 | A-POXIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | ||
| A085447-003 | A-POXIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 |
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 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085447-002 | A-POXIDE | 10MG | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085447-003 | A-POXIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085447-001 | A-POXIDE | 5MG | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | REMEDYREPACK INC. | 9aba3135-00ff-47ba-b926-55eb16b361bf | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | REMEDYREPACK INC. | 43daab7a-3809-4b13-b015-4806912c3c4a | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Coupler LLC | 54d76424-7fab-c000-e063-6294a90af43e | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 53c278b6-d22d-79bd-e063-6294a90a82cd | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Couper LLC | 511264f5-024b-350a-e063-6394a90a51e9 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Safecor Health, LLC | 60abf20f-0c6c-43b9-8b55-f4957e2a655d | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | REMEDYREPACK INC. | cba55889-e81e-404d-974b-4af484eccfb1 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Chartwell RX, LLC | dd5f82b0-5a56-4728-941a-c8c2a0d51cc4 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Mylan Institutional Inc. | 68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3cbd7cee-c4d7-4c95-93d8-09428169b937 | 2025-09-15 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | American Health Packaging | 1eb5eb7a-8c5f-43a3-9b9f-6321cdb6f6c7 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Bryant Ranch Prepack | f04714bc-4ce0-4693-9cd8-578919325474 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | e3ff8641-ae8a-4016-acb1-cb1b7890f5ed | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a57a5046-f73b-10a9-e053-2a95a90ad72f | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9e64d2d8-b12c-5639-e053-2a95a90aab80 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Clinical Solutions Wholesale, LLC | 3d4cab96-8a67-4d26-a9cc-b1a02fb6c146 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| Chlordiazepoxide Hydrochloride | CHLORDIAZEPOXIDE HYDROCHLORIDE | Clinical Solutions Wholesale, LLC | 74c4320d-c90d-436b-97da-07496ba88aed | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | Epic Pharma, LLC | 2e198c16-a929-4028-8f96-25dd23f74b10 | 2023-02-07 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | Epic Pharma LLC | 8255992f-3256-4558-bd0d-cfe350d95f25 | 2022-03-08 | Boxed warning, Warnings, Adverse reactions | CHLORDIAZEPOXIDE HYDROCHLORIDE |