Application 091071
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL
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 |
|---|---|---|---|---|---|---|---|
| A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | ||
| A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 |
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 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091071-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091071-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-05-27 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Guaifenesin and Pseudoephedrine Hydrochloride | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | c857bcd9-6696-40d5-93c0-65097598cd4b | 2022-04-08 | Warnings | Guaifenesin and Pseudoephedrine Hydrochloride |
| Guaifenesin and Pseudoephedrine Hydrochloride | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | d139fd8d-66fd-4484-8e78-ed90c505d999 | 2022-02-08 | Warnings | Guaifenesin and Pseudoephedrine Hydrochloride |
| Guaifenesin and Pseudoephedrine Hydrochloride | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | WALGREEN COMPANY | 310d14be-e7ea-44b8-8b04-cffa39440d50 | 2018-10-27 | Warnings | Guaifenesin and Pseudoephedrine Hydrochloride |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0113-2002 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | L. Perrigo Company | ANDA | Current |
| 0113-2002 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | L. Perrigo Company | ANDA | Current |
| 0363-0144 | Mucus Relief D | Guaifenesin, pseudoephedrine hydrochloride | Walgreen Company | ANDA | Current |
| 0363-0144 | Mucus Relief D | Guaifenesin, pseudoephedrine hydrochloride | Walgreen Company | ANDA | Current |
| 0536-1205 | rugby mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Rugby Laboratories | ANDA | Current |
| 11822-0144 | mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Rite Aid Corporation | ANDA | Current |
| 11822-0144 | mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Rite Aid Corporation | ANDA | Current |
| 30142-144 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | Kroger Company | ANDA | Current |
| 30142-144 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | Kroger Company | ANDA | Current |
| 30142-144 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | Kroger Company | ANDA | Current |
| 30142-144 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | Kroger Company | ANDA | Current |
| 36800-144 | TopCare Mucus D | Guaifenesin, pseudoephedrine hydrochloride | Topco Associates LLC | ANDA | Current |
| 37808-446 | Mucus Relief D | Guaifenesin, pseudoephedrine hydrochloride | H E B | ANDA | Current |
| 37808-446 | Mucus Relief D | Guaifenesin, pseudoephedrine hydrochloride | H E B | ANDA | Current |
| 37808-777 | mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | H E B | ANDA | Current |
| 37808-777 | mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | H E B | ANDA | Current |
| 41250-144 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 45802-230 | Guaifenesin and pseudoephedrine hydrochloride Extended Release | Guaifenesin, pseudoephedrine hydrochloride | Perrigo New York Inc | ANDA | Current |
| 45802-230 | Guaifenesin and pseudoephedrine hydrochloride Extended Release | Guaifenesin, pseudoephedrine hydrochloride | Perrigo New York Inc | ANDA | Current |
| 45802-230 | Guaifenesin and pseudoephedrine hydrochloride Extended Release | Guaifenesin, pseudoephedrine hydrochloride | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 46122-239 | Good Neighbor Pharmacy Mucus D | Guaifenesin, pseudoephedrine hydrochloride | Amerisource Bergen | ANDA | Current |
| 49035-729 | equate mucus d | guaifenesin, pseudoephedrine hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49035-792 | equate mucus d | guaifenesin, pseudoephedrine hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49348-113 | Sunmark mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | McKesson | ANDA | Current |
| 49348-113 | Sunmark mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-113 | Sunmark mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Strategic Sourcing Services LLC | ANDA | Current |
| 55316-144 | healthy accents mucus relief D | Guaifenesin, pseudoephedrine hydrochloride | DZA Brands LLC | ANDA | Current |
| 56062-144 | Mucus D ER | Guaifenesin, pseudoephedrine hydrochloride | Publix Super Markets Inc | ANDA | Current |
| 56062-144 | Mucus D ER | Guaifenesin, pseudoephedrine hydrochloride | Publix Super Markets Inc | ANDA | Current |
| 59779-825 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-825 | Mucus D | Guaifenesin, pseudoephedrine hydrochloride | CVS Pharmacy | ANDA | Current |
| 62011-0259 | Health Mart mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0259 | Health Mart mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0259 | Health Mart mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | McKesson | ANDA | Current |
| 63187-960 | Guaifenesin and pseudoephedrine hydrochloride Extended Release | Guaifenesin, pseudoephedrine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-960 | Guaifenesin and pseudoephedrine hydrochloride Extended Release | Guaifenesin, pseudoephedrine hydrochloride | Proficient Rx LP | ANDA | Current |
| 69256-144 | Harris Teeter Mucus Relief D | Guaifenesin, pseudoephedrine hydrochloride | Harris Teeter, LLC | ANDA | Current |
| 69256-144 | Harris Teeter Mucus Relief D | Guaifenesin, pseudoephedrine hydrochloride | Harris Teeter, LLC | ANDA | Current |
| 70000-0004 | leader mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Cardinal Health | ANDA | Current |
| 70000-0004 | leader mucus relief d | Guaifenesin, pseudoephedrine hydrochloride | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70518-0011 | Guaifenesin and pseudoephedrine hydrochloride Extended Release | Guaifenesin, pseudoephedrine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31514 | ORIG | 2015-06-02 |