Application 208369
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
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 |
|---|---|---|---|---|---|---|---|
| A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | ||
| A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 |
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 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208369-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208369-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2017-12-29 | 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 |
|---|---|---|---|---|---|---|
| Mucus Relief D | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | CVS Health Corp | 19cde6f8-649a-df69-7ee9-05da2cccba5b | 2025-12-10 | Warnings | 208369 ANDA208369 69842-211 |
| Mucus Relief D | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Rite Aid Corporation | 82654829-a2a5-06aa-930c-5bdd60e49b10 | 2025-12-10 | Warnings | 208369 ANDA208369 11822-7399 |
| Mucus Relief D | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Walgreens Company | 01047716-389b-df25-ebe6-c897fc47d3df | 2025-12-10 | Warnings | 208369 ANDA208369 0363-1604 |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Rite Aid Corporation | 9fb0c938-d24b-2371-95db-6c82d9511d72 | 2025-12-10 | Warnings | 208369 ANDA208369 11822-0046 |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Strategic Sourcing Services, LLC | 51ec068b-e219-381a-384b-a208a306d5ba | 2025-12-10 | Warnings | 208369 ANDA208369 |
| Mucus D | GUAIFENESIN 600 MG AND PSEUDOEPHEDRINE HCL 60 MG | CVS Health Corp | 284bbf6a-8b34-09b6-3115-553a9ec83122 | 2025-12-10 | Warnings | 208369 ANDA208369 69842-095 |
| Mucus Relief D | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Walgreens Company | 2619b68b-835a-c7f2-ecbc-39944d5ba8a5 | 2025-12-10 | Warnings | 208369 ANDA208369 0363-7064 |
| Guaifenesin and Pseudoephedrine HCL | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Dr. Reddys Laboratories Limited | 845a2dcc-9069-3141-ae13-f2063f36d130 | 2025-10-24 | Warnings | 208369 ANDA208369 55111-799 55111-798 |
| Mucus Relief D | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Wal-mart Stores, Inc. | f3933531-aa4d-cb67-1895-f2f14175f1d2 | 2025-10-10 | Warnings | 208369 ANDA208369 49035-261 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-1604 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Walgreens Company | ANDA | Current |
| 0363-1604 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Walgreens Company | ANDA | Current |
| 0363-1604 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Walgreens Company | ANDA | Current |
| 0363-1604 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Walgreens Company | ANDA | Current |
| 0363-7064 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Walgreens Company | ANDA | Current |
| 0363-7064 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Walgreens Company | ANDA | Current |
| 0363-7064 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Walgreens Company | ANDA | Current |
| 11822-0046 | Guaifenesin and Pseudoephedrine HCl | Guaifenesin and Pseudoephedrine HCL | Rite Aid Corporation | ANDA | Current |
| 11822-0046 | Guaifenesin and Pseudoephedrine HCl | Guaifenesin and Pseudoephedrine HCL | Rite Aid Corporation | ANDA | Current |
| 11822-7399 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Rite Aid Corporation | ANDA | Current |
| 11822-7399 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Rite Aid Corporation | ANDA | Current |
| 11822-7399 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Rite Aid Corporation | ANDA | Current |
| 49035-261 | Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg | Guaifenesin and Pseudoephedrine HCL | Wal-mart Stores, Inc. | ANDA | Current |
| 49035-261 | Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg | Guaifenesin and Pseudoephedrine HCL | Wal-mart Stores, Inc. | ANDA | Current |
| 55111-798 | Guaifenesin and Pseudoephedrine HCL | Guaifenesin and Pseudoephedrine HCL | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-798 | Guaifenesin and Pseudoephedrine HCL | Guaifenesin and Pseudoephedrine HCL | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-798 | Guaifenesin and Pseudoephedrine HCL | Guaifenesin and Pseudoephedrine HCL | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-799 | Guaifenesin and Pseudoephedrine HCL | Guaifenesin and Pseudoephedrine HCL | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-799 | Guaifenesin and Pseudoephedrine HCL | Guaifenesin and Pseudoephedrine HCL | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-799 | Guaifenesin and Pseudoephedrine HCL | Guaifenesin and Pseudoephedrine HCL | Dr. Reddys Laboratories Limited | ANDA | Current |
| 69842-095 | Mucus D | Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg | CVS Health Corp | ANDA | Current |
| 69842-095 | Mucus D | Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg | CVS Health Corp | ANDA | Current |
| 69842-211 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | CVS Health Corp | ANDA | Current |
| 69842-211 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | CVS Health Corp | ANDA | Current |
| 69842-211 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | CVS Health Corp | ANDA | Current |
| 70000-0608 | Mucus Relief D | Guaifenesin and Pseudoephedrine HCL | Cardinal Health | ANDA | Current |
| 70677-0110 | Guaifenesin and Pseudoephedrine HCl | Guaifenesin and Pseudoephedrine HCL | Strategic Sourcing Services, LLC | ANDA | Current |
| 70677-0110 | Guaifenesin and Pseudoephedrine HCl | Guaifenesin and Pseudoephedrine HCL | Strategic Sourcing Services, LLC | ANDA | Current |