Application 217280
- Type
- ANDA
- Sponsor
- ALEMBIC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG BASE | No | No |
| 002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | No | No |
| 003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 12.5MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217280-001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-24 | |
| A217280-002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-24 | |
| A217280-003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2026-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217280-001 | AB |
| A217280-002 | AB |
| A217280-003 | AB |
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 | A217280-001 | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217280-002 | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217280-001 | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217280-002 | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-24 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217280-001 | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217280-002 | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217280-003 | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2026-03-26 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217280-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217280-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217280-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217280-002 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217280-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217280-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217280-003 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Paroxetine | PAROXETINE | Alembic Pharmaceuticals Limited | 59cb7de6-483d-4007-b6ef-f10a70b872e9 | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 217280 ANDA217280 |
| Paroxetine | PAROXETINE | Alembic Pharmaceuticals Inc. | 5da839f9-e2bf-4b83-a410-1226ba4552a1 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 217280 ANDA217280 |