Application 020363
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FAMVIR | FAMCICLOVIR | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | FAMVIR | FAMCICLOVIR | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | FAMVIR | FAMCICLOVIR | TABLET;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020363-001 | FAMVIR | FAMCICLOVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | |
| N020363-002 | FAMVIR | FAMCICLOVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | |
| N020363-003 | FAMVIR | FAMCICLOVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 |
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| 2026-08 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020363-002 | FAMVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-06-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020363-003 | FAMVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-12-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020363-001 | FAMVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Famciclovir | FAMCICLOVIR | AvKARE | 5723f50e-b0fa-65f0-e063-6294a90a350f | 2026-07-21 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | AvKARE | c2b21ad5-fa83-1fb6-e053-2a95a90a3d0f | 2026-01-14 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Bryant Ranch Prepack | d3faac3a-5c8c-4987-9703-c161fb29ec56 | 2025-10-28 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | PD-Rx Pharmaceuticals, Inc. | 2c44b8d2-3b70-4e8b-af03-2e917178f761 | 2025-10-20 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Macleods Pharmaceuticals Limited | eeeee9c4-8566-4100-8ca4-3df936a3365d | 2025-09-17 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Bryant Ranch Prepack | 2c579bc7-8130-4935-a999-62b4b1c20706 | 2025-03-25 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Camber Pharmaceuticals, Inc. | 08c58224-5920-4853-8c59-ec5fbb66c2f6 | 2025-01-09 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Aurobindo Pharma Limited | fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343 | 2024-06-15 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Rising Pharma Holdings, Inc. | d5c46506-a350-44a1-9440-d939da895f16 | 2024-06-15 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Proficient Rx LP | b75abffb-0a90-4abd-8ed8-81be1d8fe364 | 2023-01-01 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Teva Pharmaceuticals USA, Inc. | 3f02042f-8f51-4ccf-b608-5dcd75d100fb | 2022-11-28 | Warnings, Adverse reactions | FAMCICLOVIR |
| Famciclovir | FAMCICLOVIR | Proficient Rx LP | 29b7ea8b-b976-45cb-9006-a27ba797b0fd | 2022-06-01 | Warnings, Adverse reactions | FAMCICLOVIR |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56927 | SUPPL | 2018-12-21 |
| 56793 | SUPPL | 2018-12-19 |
| 45345 | SUPPL | 2016-09-20 |
| 45318 | SUPPL | 2016-09-16 |
| 12481 | SUPPL | 2013-04-30 |
| 2390 | SUPPL | 2013-04-25 |
| 24840 | SUPPL | 2012-02-13 |
| 2389 | SUPPL | 2012-02-13 |
| 34552 | SUPPL | 2012-02-10 |
| 12480 | SUPPL | 2012-02-10 |
| 24839 | SUPPL | 2011-02-04 |
| 12479 | SUPPL | 2011-01-31 |
| 12478 | SUPPL | 2010-01-12 |
| 24838 | SUPPL | 2009-12-31 |
| 52927 | SUPPL | 2009-09-29 |
| 51611 | SUPPL | 2009-09-21 |
| 51610 | SUPPL | 2009-09-21 |
| 51609 | SUPPL | 2009-09-21 |
| 51150 | SUPPL | 2009-09-21 |
| 34551 | SUPPL | 2009-01-02 |
| 24837 | SUPPL | 2008-12-24 |
| 34550 | SUPPL | 2006-08-04 |
| 24836 | SUPPL | 2006-08-04 |
| 12477 | SUPPL | 2006-08-04 |
| 2388 | SUPPL | 2006-08-04 |
| 24835 | SUPPL | 2006-03-01 |
| 34549 | SUPPL | 2006-02-28 |
| 41300 | SUPPL | 2004-04-14 |
| 24834 | SUPPL | 2001-03-29 |
| 12476 | SUPPL | 2001-03-29 |
| 24833 | SUPPL | 1998-06-12 |
| 2387 | SUPPL | 1998-06-12 |
| 2386 | SUPPL | 1998-06-12 |
| 52928 | SUPPL | 1900-01-01 |