Application 076557
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 10MG;240MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076557-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2004-09-22 | e64feba35796… |
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 |
|---|---|---|---|---|---|
| 0363-0725 | Loratadine and Pseudoephedrine | Loratadine and Pseudoephedrine | Walgreen Company | ANDA | Current |
| 0363-0725 | Loratadine and Pseudoephedrine | Loratadine and Pseudoephedrine | Walgreen Company | ANDA | Current |
| 0904-5833 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Major Pharmaceuticals | ANDA | Current |
| 0904-5833 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Major Pharmaceuticals | ANDA | Current |
| 11673-165 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Target Corporation | ANDA | Current |
| 11822-9990 | Loratadine and Pseudoephedrine | LORATADINE and PSEUDOEPHEDRINE SULFATE | Rite Aid | ANDA | Current |
| 11822-9990 | Loratadine and Pseudoephedrine | LORATADINE and PSEUDOEPHEDRINE SULFATE | Rite Aid | ANDA | Current |
| 11822-9990 | Loratadine and Pseudoephedrine | LORATADINE and PSEUDOEPHEDRINE SULFATE | Rite Aid | ANDA | Current |
| 11822-9990 | Loratadine and Pseudoephedrine | LORATADINE and PSEUDOEPHEDRINE SULFATE | Rite Aid | ANDA | Current |
| 15127-717 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Select Brand | ANDA | Current |
| 21130-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Safeway Inc. | ANDA | Current |
| 21130-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Safeway Inc. | ANDA | Current |
| 21695-729 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Rebel Distributors Corp | ANDA | Current |
| 30142-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | The Kroger Company | ANDA | Current |
| 30142-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | The Kroger Company | ANDA | Current |
| 36800-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Topco Associates LLC | ANDA | Current |
| 37012-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37205-348 | Leader Allergy Relief D-24 | Loratadine and Pseudoephedrine Sulfate | Cardinal Health | ANDA | Current |
| 37808-427 | Loratadine and Pseudoephedrine Sulfate | loratadine and pseudoephedrine sulfate | HEB | ANDA | Current |
| 37808-724 | Loratadine and Pseudoephedrine Sulfate | loratadine and pseudoephedrine sulfate | HEB | ANDA | Current |
| 41163-165 | Loratadine and Pseudoephedrine | Loratadine and Pseudoephedrine | SUPERVALU INC. | ANDA | Current |
| 41250-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Meijer Distribution, Inc. | ANDA | Current |
| 41250-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Meijer Distribution, Inc. | ANDA | Current |
| 46122-167 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Amerisource Bergen | ANDA | Current |
| 46122-167 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Amerisource Bergen | ANDA | Current |
| 46122-167 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Amerisource Bergen | ANDA | Current |
| 46122-383 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | AMERISOURCE BERGEN | ANDA | Current |
| 46122-383 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | AMERISOURCE BERGEN | ANDA | Current |
| 49035-488 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | WAL-MART STORES, INC | ANDA | Current |
| 49348-543 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | STRATEGIC SOURCING SERVICES | ANDA | Current |
| 49348-543 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Sunmark | ANDA | Current |
| 49614-172 | Medicine Shoppe Allergy Relief D24 | Loratadine and Pseudoephedrine Sulfate | The Medicine Shoppe International | ANDA | Current |
| 51660-488 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Ohm Laboratories Inc. | ANDA | Current |
| 51660-491 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Ohm Laboratories Inc. | ANDA | Current |
| 51660-491 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Ohm Laboratories Inc. | ANDA | Current |
| 51660-724 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Ohm Laboratories Inc. | ANDA | Current |
| 51660-724 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Ohm Laboratories Inc. | ANDA | Current |
| 51660-724 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Ohm Laboratories Inc. | ANDA | Current |
| 56062-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Publix Super Markets Inc | ANDA | Current |
| 59779-726 | ALLERGY RELIEF-D | Loratadine and Pseudoephedrine | CVS Pharmacy | ANDA | Current |
| 59779-726 | ALLERGY RELIEF-D | Loratadine and Pseudoephedrine | CVS Pharmacy | ANDA | Current |
| 61715-016 | Loratadine and Pseudoephedrine | Loratadine and Pseudoephedrine | Kinray | ANDA | Current |
| 62011-0071 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Health Mart | ANDA | Current |
| 62011-0071 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Health Mart | ANDA | Current |
| 62011-0071 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0071 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Strategic Sourcing Services LLC | ANDA | Current |
| 63187-305 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Proficient Rx LP | ANDA | Current |
| 63187-305 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Proficient Rx LP | ANDA | Current |
| 63629-7766 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7766 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7766 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | Bryant Ranch Prepack | ANDA | Current |
| 63868-154 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Chain Drug Marketing Association Inc. | ANDA | Current |
| 63981-724 | KIRKLAND SIGNATURE ALLERCLEAR D 12 HR | loratadine and pseudoephedrine sulfate | Kirkland-COSTCO WHOLESALE COMPANY | ANDA | Current |
| 63981-724 | KIRKLAND SIGNATURE ALLERCLEAR D 24 HR | loratadine and pseudoephedrine sulfate | Kirkland-COSTCO WHOLESALE COMPANY | ANDA | Current |
| 68016-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-724 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | Chain Drug Consortium, LLC | ANDA | Current |
| 70000-0162 | Leader Allergy Relief D-24 | Loratadine and Pseudoephedrine Sulfate | Cardinal Health | ANDA | Current |
| 70000-0162 | Leader Allergy Relief D-24 | Loratadine and Pseudoephedrine Sulfate | Cardinal Health | ANDA | Current |
| 70000-0162 | Leader Allergy Relief D-24 | Loratadine and Pseudoephedrine Sulfate | Cardinal Health | ANDA | Current |
| 70000-0162 | Leader Allergy Relief D-24 | Loratadine and Pseudoephedrine Sulfate | Cardinal Health | ANDA | Current |
| 70518-0371 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0371 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0371 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0371 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0371 | Loratadine and Pseudoephedrine Sulfate | Loratadine and Pseudoephedrine Sulfate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0653 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0653 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0653 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0653 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0653 | Loratadine and Pseudoephedrine | loratadine and pseudoephedrine | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22570 | ORIG | 2011-02-15 |