Application 216082
- Type
- ANDA
- Sponsor
- GRANULES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 600MG;60MG | No | No |
| 002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1.2GM;120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | ||
| A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 |
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 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216082-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216082-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-08-22 | a67488948f0b… |
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 |
|---|---|---|---|---|---|---|
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Granules India Ltd | 75f4ff44-02e7-4a23-a394-85fe8b442e1a | 2025-12-02 | Warnings | 216082 ANDA216082 |