Application 207467
- Type
- ANDA
- Sponsor
- TECH ORGANIZED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEVIRAPINE | NEVIRAPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | NEVIRAPINE | NEVIRAPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207467-001 | NEVIRAPINE | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | ||
| A207467-002 | NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 |
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 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207467-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207467-002 | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2017-07-31 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Nevirapine | NEVIRAPINE | Mylan Pharmaceuticals Inc. | c6e93829-7024-48f6-8023-da6ff27dfc0a | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Nevirapine NEVIRAPINE |
| NEVIRAPINE | NEVIRAPINE | Micro Labs Limited | fbd628db-4076-4fe0-8323-9cc33ae92e42 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | NEVIRAPINE NEVIRAPINE |
| Nevirapine | NEVIRAPINE | Mylan Pharmaceuticals Inc. | 690da74b-2481-47fc-93ae-8340e0caf0a4 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | Nevirapine NEVIRAPINE |
| Nevirapine | NEVIRAPINE | Aurobindo Pharma Limited | 8dfe86aa-ea5d-48d2-94a8-1a5506055d70 | 2024-09-04 | Boxed warning, Warnings, Adverse reactions | Nevirapine NEVIRAPINE |
| NEVIRAPINE | NEVIRAPINE | Macleods Pharmaceuticals Limited | 2620b114-f53f-44f1-8708-697e86343090 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | NEVIRAPINE NEVIRAPINE |
| Nevirapine | NEVIRAPINE | Aurobindo Pharma Limited | 5f6c3eed-2a5d-46ed-9a7c-59715f338a15 | 2024-05-20 | Boxed warning, Warnings, Adverse reactions | Nevirapine NEVIRAPINE |
| Nevirapine | NEVIRAPINE | Macleods Pharmaceuticals Limited | effb86cc-4b80-4fac-aaa3-9f373b3d0f7d | 2023-08-16 | Boxed warning, Warnings, Adverse reactions | Nevirapine NEVIRAPINE |
| Nevirapine | NEVIRAPINE | Camber Pharmaceuticals, Inc. | 61409678-d2f6-42cd-b03d-b26b11b39641 | 2022-08-03 | Boxed warning, Warnings, Adverse reactions | Nevirapine NEVIRAPINE |
| Nevirapine | NEVIRAPINE | Amneal Pharmaceuticals LLC | 4f065674-4719-4c79-ba0d-549040d77f17 | 2012-08-30 | Boxed warning, Warnings, Adverse reactions | Nevirapine NEVIRAPINE |