Application 206941
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|---|---|---|---|---|---|---|
| A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | ||
| A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 |
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 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2017-03-17 | 782e0a99824c… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 58602-825 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-825 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-825 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-849 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-849 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-849 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-849 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-849 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-849 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 58602-871 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Aurohealth LLC | ANDA | Current |
| 60000-057 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-057 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-057 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-057 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-057 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-058 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-058 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-058 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-058 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Ahold U.S.A., Inc, | ANDA | Current |
| 62011-0346 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0346 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0346 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | McKESSON Corporation | ANDA | Current |
| 62011-0346 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0360 | MAXIMUM STRENGTH MUCUS RELIEF DM | Guaifenesin and Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0360 | MAXIMUM STRENGTH MUCUS RELIEF DM | Guaifenesin and Dextromethorphan HBr | McKESSON Corporation | ANDA | Current |
| 62011-0360 | MAXIMUM STRENGTH MUCUS RELIEF DM | Guaifenesin and Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0360 | MAXIMUM STRENGTH MUCUS RELIEF DM | Guaifenesin and Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 67091-314 | Mucus Relief DM Expectorant and Cough Suppressant | Guaifenesin and Dextromethorphan HBr | Winco Foods, LLC. | ANDA | Current |
| 67091-314 | Mucus Relief DM Expectorant and Cough Suppressant | Guaifenesin and Dextromethorphan HBr | Winco Foods, LLC. | ANDA | Current |
| 67091-314 | Mucus Relief DM Expectorant and Cough Suppressant | Guaifenesin and Dextromethorphan HBr | Winco Foods, LLC. | ANDA | Current |
| 67091-314 | Mucus Relief DM Expectorant and Cough Suppressant | Guaifenesin and Dextromethorphan HBr | Winco Foods, LLC. | ANDA | Current |
| 67091-315 | Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength | Guaifenesin and Dextromethorphan HBr | Winco Foods, LLC. | ANDA | Current |
| 67091-315 | Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength | Guaifenesin and Dextromethorphan HBr | Winco Foods, LLC. | ANDA | Current |
| 67091-315 | Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength | Guaifenesin and Dextromethorphan HBr | Winco Foods, LLC. | ANDA | Current |
| 67091-315 | Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength | Guaifenesin and Dextromethorphan HBr | Winco Foods, LLC. | ANDA | Current |
| 68016-315 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-315 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-315 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-315 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Chain Drug Consortium, LLC | ANDA | Current |
| 68788-7317 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7317 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68998-950 | Mucus Relief DM MAX | Guaifenesin and Dextromethorphan HBr | Marc Glassman, Inc. | ANDA | Current |
| 68998-950 | Mucus Relief DM MAX | Guaifenesin and Dextromethorphan HBr | Marc Glassman, Inc. | ANDA | Current |
| 68998-950 | Mucus Relief DM MAX | Guaifenesin and Dextromethorphan HBr | Marc Glassman, Inc. | ANDA | Current |
| 68998-950 | Mucus Relief DM MAX | Guaifenesin and Dextromethorphan HBr | Marc Glassman, Inc. | ANDA | Current |
| 69842-057 | Mucus DM Extended Release | Guaifenesin and Dextromethorphan HBr | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-057 | Mucus DM Extended Release | Guaifenesin and Dextromethorphan HBr | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-057 | Mucus DM Extended Release | Guaifenesin and Dextromethorphan HBr | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-057 | Mucus DM Extended Release | Guaifenesin and Dextromethorphan HBr | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-059 | Maximum Strength Mucus DM Extended Release | Guaifenesin and Dextromethorphan HBr | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-059 | Maximum Strength Mucus DM Extended Release | Guaifenesin and Dextromethorphan HBr | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-059 | Maximum Strength Mucus DM Extended Release | Guaifenesin and Dextromethorphan HBr | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-059 | Maximum Strength Mucus DM Extended Release | Guaifenesin and Dextromethorphan HBr | CVS Pharmacy, Inc. | ANDA | Current |
| 71179-011 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | VESPYR BRANDS, INC. | ANDA | Current |
| 72036-980 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Harris Teeter | ANDA | Current |
| 72036-980 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Harris Teeter | ANDA | Current |
| 72036-980 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Harris Teeter | ANDA | Current |
| 72036-980 | Mucus Relief DM | Guaifenesin and Dextromethorphan HBr | Harris Teeter | ANDA | Current |
| 79395-002 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Chalkboard Health | ANDA | Current |
| 79395-002 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Chalkboard Health | ANDA | Current |
| 79395-002 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Chalkboard Health | ANDA | Current |