Application 076968
- Type
- ANDA
- Sponsor
- OXFORD PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
| 003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | No | No |
| 004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076968-001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2010-06-21 | |
| A076968-002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2010-06-21 | |
| A076968-003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2010-06-21 | |
| A076968-004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2010-06-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076968-001 | AB |
| A076968-002 | AB |
| A076968-003 | AB |
| A076968-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A076968-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2010-06-21 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A076968-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2010-06-21 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A076968-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2010-06-21 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A076968-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2010-06-21 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A076968-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A076968-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A076968-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A076968-004 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| paroxetine hydrochloride | PAROXETINE HYDROCHLORIDE | Bryant Ranch Prepack | c3c204df-6b7d-42fb-8794-4f38064ed963 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | 076968 ANDA076968 |
| paroxetine hydrochloride | PAROXETINE HYDROCHLORIDE | Oxford Pharmaceuticals, LLC | 25182b68-8f7a-48e8-9788-6818b0984b29 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | 076968 ANDA076968 69584-672 69584-673 69584-671 69584-674 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69584-671 | paroxetine hydrochloride | paroxetine hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-672 | paroxetine hydrochloride | paroxetine hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-673 | paroxetine hydrochloride | paroxetine hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-674 | paroxetine hydrochloride | paroxetine hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |