Application 206271
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEVIRAPINE | NEVIRAPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206271-001 | NEVIRAPINE | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-11-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A206271-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-11-09 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A206271-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-11-09 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206271-001 | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-11-09 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | A206271-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206271-001 | 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 |
|---|---|---|---|---|---|---|
| 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 | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.