Application 214445
- Type
- ANDA
- Sponsor
- RUBICON RESEARCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BACLOFEN | BACLOFEN | SOLUTION;ORAL | 5MG/5ML | No | No |
| 002 | BACLOFEN | BACLOFEN | SOLUTION;ORAL | 10MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214445-001 | BACLOFEN | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | ||
| A214445-002 | BACLOFEN | BACLOFEN | 10MG/5ML | SOLUTION / ORAL | AA | 2025-06-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214445-002 | AA |
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 | A214445-001 | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214445-002 | BACLOFEN | 10MG/5ML | SOLUTION / ORAL | AA | 2025-06-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214445-001 | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214445-002 | BACLOFEN | 10MG/5ML | SOLUTION / ORAL | AA | 2025-06-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214445-001 | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214445-002 | BACLOFEN | 10MG/5ML | SOLUTION / ORAL | AA | 2025-06-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214445-001 | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214445-001 | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214445-001 | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214445-001 | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | 2680178bc6a6… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214445-001 | BACLOFEN | 5MG/5ML | SOLUTION / ORAL | 2024-12-06 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214445-002 | BACLOFEN | 10MG/5ML | SOLUTION / ORAL | AA | 2025-06-03 | 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 | A214445-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214445-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214445-002 | AA | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214445-002 | AA | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214445-001 | PC | 2025-07-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214445-001 | PC | 2025-07-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214445-001 | PC | 2025-07-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214445-001 | PC | 2025-07-14 | b8a1b40f171c… |
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 |
|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | Trifluent Pharma, LLC | 890df151-f4eb-4244-97c4-f1f10912e753 | 2025-07-21 | Warnings, Adverse reactions | 214445 ANDA214445 |
| BACLOFEN | BACLOFEN | Advagen Pharma Ltd | 2a43830f-a28b-ca15-e063-6294a90a6b1a | 2025-06-12 | Warnings, Adverse reactions | 214445 ANDA214445 |
| Baclofen | BACLOFEN | Advagen Pharma Ltd., | 75ab298b-b2a7-458f-accc-5bfc89b89a16 | 2025-06-11 | Warnings, Adverse reactions | 214445 ANDA214445 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74113 | ORIG | 2025-02-10 |