Application 020518
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RETROVIR | ZIDOVUDINE | TABLET;ORAL | 200MG | No | No |
| 002 | RETROVIR | ZIDOVUDINE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N020518-001 | RETROVIR | ZIDOVUDINE | 200MG | TABLET / ORAL | 1995-12-19 | ||
| N020518-002 | RETROVIR | ZIDOVUDINE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 |
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 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020518-002 | RETROVIR | 300MG | TABLET / ORAL | RLD | 1996-10-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020518-002 | RETROVIR | 300MG | TABLET / ORAL | RLD | 1996-10-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1996-10-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-10-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020518-001 | RETROVIR | 200MG | TABLET / ORAL | 1995-12-19 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020518-002 | RETROVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1996-10-04 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Zidovudine | ZIDOVUDINE | Coupler LLC | 437f55b2-f6d9-0065-e063-6294a90ab929 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | ZIDOVUDINE |
| Zidovudine | ZIDOVUDINE | Aurobindo Pharma Limited | 51abd2ce-6be1-412d-b806-5f24935ac5e3 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | ZIDOVUDINE |
| Zidovudine | ZIDOVUDINE | Aurobindo Pharma Limited | 9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | ZIDOVUDINE |
| RETROVIR | ZIDOVUDINE | ViiV Healthcare Company | 6df09f15-b102-431c-adde-d7aeef6f5d84 | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | RETROVIR ZIDOVUDINE |
| Zidovudine | ZIDOVUDINE | Aurobindo Pharma Limited | e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4 | 2024-01-25 | Boxed warning, Warnings, Adverse reactions | ZIDOVUDINE |
| Zidovudine | ZIDOVUDINE | Camber Pharmaceuticals, Inc. | ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4 | 2023-05-15 | Boxed warning, Warnings, Adverse reactions | ZIDOVUDINE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 34756 | SUPPL | 2015-01-08 |
| 25098 | SUPPL | 2014-12-31 |
| 34755 | SUPPL | 2012-06-06 |
| 25097 | SUPPL | 2012-06-04 |
| 25096 | SUPPL | 2011-12-01 |
| 34754 | SUPPL | 2011-11-25 |
| 25095 | SUPPL | 2010-05-21 |
| 34753 | SUPPL | 2010-05-18 |
| 25094 | SUPPL | 2010-01-06 |
| 12674 | SUPPL | 2009-11-23 |
| 12673 | SUPPL | 2008-09-25 |
| 2654 | SUPPL | 2008-09-23 |
| 2653 | SUPPL | 2006-12-04 |
| 34752 | SUPPL | 2006-11-22 |
| 2652 | SUPPL | 2006-05-18 |
| 12672 | SUPPL | 2006-05-16 |
| 20696 | SUPPL | 2005-04-19 |
| 34751 | SUPPL | 2004-03-11 |
| 25093 | SUPPL | 2004-03-11 |
| 34749 | SUPPL | 2003-04-25 |
| 34750 | SUPPL | 2003-04-04 |
| 2651 | SUPPL | 2002-12-18 |
| 2650 | SUPPL | 2002-02-21 |
| 34748 | SUPPL | 2001-03-30 |
| 25092 | SUPPL | 2001-03-30 |