Application 218417
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | SUSPENSION, EXTENDED RELEASE;ORAL | EQ 30MG HYDROBROMIDE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218417-001 | DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2026-04-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218417-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2026-04-15 | 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 |
|---|---|---|---|---|---|---|
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | Aurohealth LLC | fc328034-ad2a-4f7d-81cf-f4da4e64f5d7 | 2026-05-13 | Warnings | 218417 ANDA218417 |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | Aurohealth LLC | 0fb8cdfc-3fa0-4773-813a-04c82b003bdf | 2026-05-13 | Warnings | 218417 ANDA218417 |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | Aurohealth LLC | 4fde00af-3824-44f1-8a5f-d88518e0a8c8 | 2026-05-04 | Warnings | 218417 ANDA218417 |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | Aurohealth LLC | 759acdcd-d8d0-41d0-8b80-7f81fe196a9f | 2026-05-04 | Warnings | 218417 ANDA218417 |