Application 217340
- Type
- ANDA
- Sponsor
- DR REDDYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 30MG;600MG | No | No |
| 002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 60MG;1.2GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217340-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-01 | ||
| A217340-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217340-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-01 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217340-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217340-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-01 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217340-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-01 | 9b2671bbb829… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217340-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-01 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217340-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-01 | 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 |
|---|---|---|---|---|---|---|
| Members Mark Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | SAM'S WEST INC | 2b59f90b-b8fc-03c0-3527-a8efa97fbfe3 | 2025-11-30 | Warnings | 217340 ANDA217340 |
| Guaifenesin and Dextromethorphan HBR | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Dr. Reddy's Laboratories Inc. | 5e95d8c0-d521-45b6-ccaf-7786fbd14d5c | 2025-11-30 | Warnings | 217340 ANDA217340 |
| Guaifenesin and Dextromethorphan HBR | GUAIFENESIN AND DEXTROMETHORPHAN HBR | CVS Pharmacy | 7942eeae-0528-4416-bd2f-b05acc71c0a9 | 2024-11-10 | Warnings | 217340 ANDA217340 |
| Guaifenesin and Dextromethorphan HBR | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Dr. Reddy's Laboratories Inc. | 49d7f70d-ff79-0708-3eda-efa5bf61da6c | 2024-03-19 | Warnings | 217340 ANDA217340 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.