Application 019032
- Type
- NDA
- Sponsor
- PROMIUS PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TENEX | GUANFACINE HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE | Yes | No |
| 002 | TENEX | GUANFACINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | Yes | No |
| 003 | TENEX | GUANFACINE HYDROCHLORIDE | TABLET;ORAL | EQ 3MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019032-001 | TENEX | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-27 | |
| N019032-002 | TENEX | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | |
| N019032-003 | TENEX | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-11-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-11-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-11-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-11-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-11-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-11-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019032-001 | TENEX | EQ 1MG BASE | TABLET / ORAL | RLD | 1986-10-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019032-002 | TENEX | EQ 2MG BASE | TABLET / ORAL | RLD | 1988-11-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019032-003 | TENEX | EQ 3MG BASE | TABLET / ORAL | 1988-11-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019032-001 | TENEX | EQ 1MG BASE | TABLET / ORAL | RLD | 1986-10-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019032-002 | TENEX | EQ 2MG BASE | TABLET / ORAL | RLD | 1988-11-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019032-003 | TENEX | EQ 3MG BASE | TABLET / ORAL | 1988-11-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019032-001 | TENEX | EQ 1MG BASE | TABLET / ORAL | RLD | 1986-10-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019032-002 | TENEX | EQ 2MG BASE | TABLET / ORAL | RLD | 1988-11-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019032-003 | TENEX | EQ 3MG BASE | TABLET / ORAL | 1988-11-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-27 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-11-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1986-10-27 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1988-11-07 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 1988-11-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1986-10-27 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1988-11-07 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 1988-11-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1986-10-27 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1988-11-07 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 1988-11-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1986-10-27 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1988-11-07 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019032-003 | TENEX | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 1988-11-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019032-001 | TENEX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1986-10-27 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019032-002 | TENEX | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1988-11-07 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Guanfacine Hydrochloride | GUANFACINE HYDROCHLORIDE | REMEDYREPACK INC. | 1b1063ba-fee3-4540-9139-db4b915f82e2 | 2026-04-10 | Adverse reactions | GUANFACINE HYDROCHLORIDE |
| Guanfacine Hydrochloride | GUANFACINE HYDROCHLORIDE | American Health Packaging | c38bf26f-8a98-4baa-9abb-c83f812900a1 | 2024-08-29 | Adverse reactions | GUANFACINE HYDROCHLORIDE |
| Guanfacine Hydrochloride | GUANFACINE HYDROCHLORIDE | NORTHSTAR RX LLC | 83d0739b-46fd-6228-e85c-089611067a35 | 2024-07-15 | Adverse reactions | GUANFACINE HYDROCHLORIDE |
| Guanfacine Hydrochloride | GUANFACINE HYDROCHLORIDE | XIROMED, LLC | 4f1e668a-37dd-44f4-ae99-3a1f6dba3eea | 2024-02-24 | Adverse reactions | GUANFACINE HYDROCHLORIDE |
| GUANFACINE | GUANFACINE HYDROCHLORIDE | Aurobindo Pharma Limited | e6d4fc3d-4169-44f1-bcb9-1188de40d4e5 | 2023-08-08 | Adverse reactions | GUANFACINE HYDROCHLORIDE |
| Guanfacine Hydrochloride | GUANFACINE HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 14146031-8d56-469b-8de8-fe3cf1712e78 | 2021-03-30 | Adverse reactions | GUANFACINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.