Application 020482
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRECOSE | ACARBOSE | TABLET;ORAL | 50MG | Yes | No |
| 002 | PRECOSE | ACARBOSE | TABLET;ORAL | 100MG | Yes | No |
| 004 | PRECOSE | ACARBOSE | TABLET;ORAL | 25MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020482-001 | PRECOSE | ACARBOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | |
| N020482-002 | PRECOSE | ACARBOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | |
| N020482-004 | PRECOSE | ACARBOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020482-002 | PRECOSE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020482-004 | PRECOSE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1997-05-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020482-001 | PRECOSE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-09-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | N020482-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020482-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020482-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020482-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020482-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020482-004 | 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 |
|---|---|---|---|---|---|---|
| Acarbose | ACARBOSE | Bryant Ranch Prepack | 067c0adc-7322-489d-9baa-1d061b37be36 | 2026-07-16 | Adverse reactions | ACARBOSE |
| Acarbose | ACARBOSE | Strides Pharma Science Limited | 656769ee-e292-4950-83df-a38e6b1a9d6e | 2026-07-15 | Adverse reactions | ACARBOSE |
| Acarbose | ACARBOSE | PD-Rx Pharmaceuticals, Inc. | 722ce9eb-8f7b-4651-a287-d53dd7ab3707 | 2026-06-24 | Adverse reactions | ACARBOSE |
| Acarbose | ACARBOSE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 29939129-7d09-4c22-bf3e-491a8a97f4c4 | 2026-06-18 | Adverse reactions | ACARBOSE |
| Acarbose | ACARBOSE | Chartwell RX, LLC | d1b627e1-d78d-47dd-93f5-2bf4998466ba | 2025-12-09 | Adverse reactions | ACARBOSE |
| Acarbose | ACARBOSE | Hikma Pharmaceuticals USA Inc. | 352dd336-d3f9-4ac5-a000-91d3aef7aca3 | 2024-07-19 | Adverse reactions | ACARBOSE |
| Acarbose | ACARBOSE | Bryant Ranch Prepack | 1ba7a072-03b0-41f2-be7a-101145bdef3a | 2023-11-22 | Adverse reactions | ACARBOSE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43353-908 | Precose | Acarbose | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 43353-951 | Acarbose | acarbose | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 47781-340 | Acarbose | acarbose | Alvogen, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-340 | Acarbose | acarbose | Alvogen, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-341 | Acarbose | acarbose | Alvogen, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-341 | Acarbose | acarbose | Alvogen, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-342 | Acarbose | acarbose | Alvogen, Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-342 | Acarbose | acarbose | Alvogen, Inc. | NDA AUTHORIZED GENERIC | Current |
| 50090-4115 | Acarbose | acarbose | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-4115 | Acarbose | acarbose | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-4116 | Acarbose | acarbose | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50419-861 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-861 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-861 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-862 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-862 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-862 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-863 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-863 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-863 | Precose | Acarbose | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57650 | ORIG | 2019-02-15 |
| 34697 | SUPPL | 2015-03-27 |
| 2589 | SUPPL | 2015-03-11 |
| 2588 | SUPPL | 2012-03-02 |
| 34696 | SUPPL | 2012-03-01 |
| 34695 | SUPPL | 2011-03-28 |
| 25024 | SUPPL | 2011-03-25 |
| 34694 | SUPPL | 2008-08-26 |
| 2587 | SUPPL | 2008-08-25 |
| 34693 | SUPPL | 2005-08-03 |
| 2586 | SUPPL | 2005-08-03 |
| 25023 | SUPPL | 2002-10-29 |
| 20676 | SUPPL | 1999-08-16 |
| 2585 | SUPPL | 1999-08-16 |
| 41389 | SUPPL | 1998-09-29 |
| 25022 | SUPPL | 1998-09-29 |
| 20675 | SUPPL | 1998-09-29 |
| 2584 | SUPPL | 1998-09-29 |