Application 207342
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GUAIFENESIN | GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 600MG | No | No |
| 002 | GUAIFENESIN | GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 1.2GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207342-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | ||
| A207342-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 |
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 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 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 |
|---|---|---|---|---|---|
| 0363-0832 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0363-0832 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0363-0832 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0363-0832 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0363-0931 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0363-0931 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0363-0931 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0363-0931 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0363-0931 | Mucus Relief Extended Release | Guaifenesin | Walgreens | ANDA | Current |
| 0536-1163 | Mucus Relief Extended Release | Guaifenesin | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1163 | Mucus Relief Extended Release | Guaifenesin | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1163 | Mucus Relief Extended Release | Guaifenesin | Rugby Laboratories, Inc. | ANDA | Current |
| 0904-6718 | Mucus Relief Extended Release | Guaifenesin | Major Pharmaceuticals | ANDA | Current |
| 0904-6718 | Mucus Relief Extended Release | Guaifenesin | Major Pharmaceuticals | ANDA | Current |
| 0904-6718 | Mucus Relief Extended Release | Guaifenesin | Major Pharmaceuticals | ANDA | Current |
| 11673-731 | Mucus Relief Extended-Release | Guaifenesin | TARGET Corporation | ANDA | Current |
| 11673-731 | Mucus Relief Extended-Release | Guaifenesin | TARGET Corporation | ANDA | Current |
| 11673-731 | Mucus Relief Extended-Release | Guaifenesin | TARGET Corporation | ANDA | Current |
| 11673-732 | Mucus Relief Extended Release | Guaifenesin | TARGET Corporation | ANDA | Current |
| 11673-732 | Mucus Relief Extended Release | Guaifenesin | TARGET Corporation | ANDA | Current |
| 11673-732 | Mucus Relief Extended Release | Guaifenesin | TARGET Corporation | ANDA | Current |
| 11822-0731 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-0731 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-0732 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-0732 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-0732 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-2252 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-2252 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-3252 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-7329 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 11822-7329 | Mucus Relief | Guaifenesin | Rite Aid Corporation | ANDA | Current |
| 36800-137 | Mucus Relief | Guaifenesin | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-137 | Mucus Relief | Guaifenesin | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-137 | Mucus Relief | Guaifenesin | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-137 | Mucus Relief | Guaifenesin | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-932 | Mucus Relief | Guaifenesin | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-932 | Mucus Relief | Guaifenesin | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-932 | Mucus Relief | Guaifenesin | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-932 | Mucus Relief | Guaifenesin | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 37012-727 | Mucus Relief | Guaifenesin | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-727 | Mucus Relief | Guaifenesin | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-727 | Mucus Relief | Guaifenesin | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-728 | Mucus Relief | Guaifenesin | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-728 | Mucus Relief | Guaifenesin | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-728 | Mucus Relief | Guaifenesin | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37808-762 | Mucus Relief Extended Release | Guaifenesin | H E B | ANDA | Current |
| 37808-762 | Mucus Relief Extended Release | Guaifenesin | H E B | ANDA | Current |
| 37808-762 | Mucus Relief Extended Release | Guaifenesin | H E B | ANDA | Current |
| 37808-935 | Mucus Relief | Guaifenesin | H E B | ANDA | Current |
| 37808-935 | Mucus Relief | Guaifenesin | H E B | ANDA | Current |
| 41163-731 | Mucus Relief | Guaifenesin | EQUALINE (SuperValu) | ANDA | Current |
| 41163-731 | Mucus Relief | Guaifenesin | EQUALINE (SuperValu) | ANDA | Current |
| 41163-731 | Mucus Relief | Guaifenesin | EQUALINE (SuperValu) | ANDA | Current |
| 41250-732 | Mucus Relief Extended Release | Guaifenesin | MEIJER, INC. | ANDA | Current |
| 41250-732 | Mucus Relief Extended Release | Guaifenesin | MEIJER, INC. | ANDA | Current |
| 41520-731 | Mucus Relief Extended Release | Guaifenesin | Care One (American Sales Company) | ANDA | Current |
| 41520-731 | Mucus Relief Extended Release | Guaifenesin | Care One (American Sales Company) | ANDA | Current |
| 41520-731 | Mucus Relief Extended Release | Guaifenesin | Care One (American Sales Company) | ANDA | Current |
| 41520-732 | Mucus Relief | Guaifenesin | Care One (American Sales Company) | ANDA | Current |
| 41520-732 | Mucus Relief | Guaifenesin | Care One (American Sales Company) | ANDA | Current |
| 41520-732 | Mucus Relief | Guaifenesin | Care One (American Sales Company) | ANDA | Current |
| 55154-4153 | Mucus Relief Extended Release | Guaifenesin | Cardinal Health 107, LLC | ANDA | Current |
| 55315-732 | Mucus Relief Extended Release | Guaifenesin | Freds Inc | ANDA | Current |
| 55315-732 | Mucus Relief Extended Release | Guaifenesin | Freds Inc | ANDA | Current |
| 55319-732 | Mucus Relief Extended Release | Guaifenesin | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-732 | Mucus Relief Extended Release | Guaifenesin | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55910-732 | Mucus Relief | Guaifenesin | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-732 | Mucus Relief | Guaifenesin | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-732 | Mucus Relief | Guaifenesin | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-732 | Mucus Relief | Guaifenesin | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-739 | Mucus Relief | Guaifenesin | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-739 | Mucus Relief | Guaifenesin | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-739 | Mucus Relief | Guaifenesin | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-739 | Mucus Relief | Guaifenesin | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 59726-831 | Mucus Relief | Guaifenesin | P & L Development, LLC | ANDA | Current |
| 59726-831 | Mucus Relief | Guaifenesin | P & L Development, LLC | ANDA | Current |
| 59726-832 | Mucus Relief | Guaifenesin | P & L Development, LLC | ANDA | Current |
| 59726-832 | Mucus Relief | Guaifenesin | P & L Development, LLC | ANDA | Current |
| 62011-0377 | Mucus Relief Extended Release | Guaifenesin | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0377 | Mucus Relief Extended Release | Guaifenesin | Strategic Sourcing Services LLC | ANDA | Current |