Application 208468
- Type
- ANDA
- Sponsor
- CHEMI SPA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLATIRAMER ACETATE | GLATIRAMER ACETATE | INJECTABLE;SUBCUTANEOUS | 20MG/ML | No | No |
| 002 | GLATIRAMER ACETATE | GLATIRAMER ACETATE | INJECTABLE;SUBCUTANEOUS | 40MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208468-001 | GLATIRAMER ACETATE | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | |
| A208468-002 | GLATIRAMER ACETATE | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208468-001 | AP |
| A208468-002 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208468-001 | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208468-002 | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208468-001 | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208468-002 | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208468-001 | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208468-002 | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208468-001 | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208468-002 | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208468-001 | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208468-002 | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE / SUBCUTANEOUS | AP | 2025-05-07 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208468-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208468-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208468-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208468-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208468-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208468-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208468-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208468-002 | AP | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208468-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208468-002 | AP | 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 |
|---|---|---|---|---|---|---|
| GLATIRAMER ACETATE | GLATIRAMER ACETATE | Zydus Pharmaceuticals USA Inc. | 0aa4ff2a-ce8e-46cd-830f-a264cc582be2 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | 208468 ANDA208468 |
| GLATIRAMER ACETATE | GLATIRAMER ACETATE | Italfarmaco SpA | 1b3a60de-2191-4b15-be69-01329da87711 | 2025-10-31 | 208468 ANDA208468 |