Application 076050
- Type
- ANDA
- Sponsor
- PERRIGO PHARMA INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 5MG;120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 |
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 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 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 |
|---|---|---|---|---|---|
| 0113-2007 | Allergy and Congestion Relief | loratadine, Pseudoephedrine sulfate | L. Perrigo Company | ANDA | Current |
| 0113-2007 | Allergy and Congestion Relief | loratadine, Pseudoephedrine sulfate | L. Perrigo Company | ANDA | Current |
| 0113-2007 | Allergy and Congestion Relief | loratadine, Pseudoephedrine sulfate | L. Perrigo Company | ANDA | Current |
| 0113-7777 | perrigo allergy d | loratadine, Pseudoephedrine sulfate | L. Perrigo Company | ANDA | Current |
| 0363-0617 | Wal itin D | Loratadine, Pseudoephedrine | Walgreen Company | ANDA | Current |
| 0363-0617 | Wal itin D | Loratadine, Pseudoephedrine | Walgreen Company | ANDA | Current |
| 0363-1133 | 12 hour allergy and congestion | loratadine, Pseudoephedrine sulfate | Walgreen Company | ANDA | Current |
| 0363-1133 | 12 hour allergy and congestion | loratadine, Pseudoephedrine sulfate | Walgreen Company | ANDA | Current |
| 0363-1133 | 12 hour allergy and congestion | loratadine, Pseudoephedrine sulfate | Walgreen Company | ANDA | Current |
| 0363-7023 | allergy relief d 12 | loratadine, Pseudoephedrine sulfate | Walgreen Company | ANDA | Current |
| 0573-2660 | ALAVERT ALLERGY SINUS D-12 | loratadine, pseudoephedrine sulfate | Wyeth Consumer Healthcare LLC | ANDA | Current |
| 0573-2660 | ALAVERT ALLERGY SINUS D-12 | loratadine, pseudoephedrine sulfate | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | ANDA | Current |
| 0573-2660 | ALAVERT ALLERGY SINUS D-12 | loratadine, pseudoephedrine sulfate | Wyeth Consumer Healthcare LLC | ANDA | Current |
| 11822-0013 | Allergy and Congestion Relief | Loratadine, Pseudoephedrine | Rite Aid Corporation | ANDA | Current |
| 11822-1019 | allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Rite Aid Corporation | ANDA | Current |
| 11822-1019 | allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Rite Aid Corporation | ANDA | Current |
| 11822-1019 | allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Rite Aid Corporation | ANDA | Current |
| 11822-1055 | Allergy Relief D | loratadine, Pseudoephedrine sulfate | Rite Aid Corporation | ANDA | Current |
| 11822-1055 | Allergy Relief D | loratadine, Pseudoephedrine sulfate | Rite Aid Corporation | ANDA | Current |
| 21130-007 | Signature Care Allergy and Congestion Relief | Loratadine, Pseudoephedrine | Safeway | ANDA | Current |
| 21130-007 | Signature Care Allergy and Congestion Relief | Loratadine, Pseudoephedrine | Safeway | ANDA | Current |
| 21130-007 | Signature Care Allergy and Congestion Relief | Loratadine, Pseudoephedrine | Safeway | ANDA | Current |
| 21130-482 | signature care allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Safeway | ANDA | Current |
| 21130-482 | signature care allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Safeway | ANDA | Current |
| 21130-482 | signature care allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Safeway | ANDA | Current |
| 21130-482 | signature care allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Safeway | ANDA | Current |
| 30142-013 | Allergy and congestion relief | Loratadine, Pseudoephedrine | Kroger Company | ANDA | Current |
| 30142-786 | allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Kroger Company | ANDA | Current |
| 30142-786 | allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Kroger Company | ANDA | Current |
| 30142-786 | allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Kroger Company | ANDA | Current |
| 36800-611 | topcare allergy and congestion relief | loratadine, pseudoephedrine sulfate | Topco Associates LLC | ANDA | Current |
| 36800-611 | topcare allergy and congestion relief | loratadine, pseudoephedrine sulfate | Topco Associates LLC | ANDA | Current |
| 36800-611 | topcare allergy and congestion relief | loratadine, pseudoephedrine sulfate | Topco Associates LLC | ANDA | Current |
| 36800-611 | topcare allergy and congestion relief | loratadine, pseudoephedrine sulfate | Topco Associates LLC | ANDA | Current |
| 37012-013 | Allergy Relief D | Loratadine, Pseudoephedrine | Shopko Stores Operating Co., LLC | ANDA | Current |
| 41163-013 | equaline allergy and congestion relief | Loratadine, Pseudoephedrine | Supervalu Inc | ANDA | Current |
| 41163-861 | equaline allergy and congestion relief | loratadine, Pseudoephedrine sulfate | Supervalu Inc | ANDA | Current |
| 41250-444 | Allergy Relief D | Loratadine, Pseudoephedrine | Meijer Distribution Inc | ANDA | Current |
| 41250-954 | allergy relief d | loratadine, Pseudoephedrine sulfate | Meijer Distribution Inc | ANDA | Current |
| 41250-954 | allergy relief d | loratadine, Pseudoephedrine sulfate | Meijer Distribution Inc | ANDA | Current |
| 41250-954 | allergy relief d | loratadine, Pseudoephedrine sulfate | Meijer Distribution Inc | ANDA | Current |
| 41520-013 | CareOne Allergy and congestion relief | Loratadine, Pseudoephedrine | American Sales Company | ANDA | Current |
| 41520-013 | CareOne Allergy and congestion relief | Loratadine, Pseudoephedrine | American Sales Company | ANDA | Current |
| 41520-013 | CareOne Allergy and congestion relief | Loratadine, Pseudoephedrine | American Sales Company | ANDA | Current |
| 41520-918 | careone allergy and congestion relief | loratadine, Pseudoephedrine sulfate | American Sales Company | ANDA | Current |
| 41520-918 | careone allergy and congestion relief | loratadine, Pseudoephedrine sulfate | American Sales Company | ANDA | Current |
| 41520-918 | careone allergy and congestion relief | loratadine, Pseudoephedrine sulfate | American Sales Company | ANDA | Current |
| 45802-106 | Loratadine D | Loratadine, Pseudoephedrine | Perrigo New York Inc | ANDA | Current |
| 45802-122 | loratadine D | loratadine, Pseudoephedrine sulfate | Perrigo New York Inc | ANDA | Current |
| 45802-122 | loratadine D | loratadine, Pseudoephedrine sulfate | Perrigo New York Inc | ANDA | Current |
| 45802-122 | loratadine D | loratadine, Pseudoephedrine sulfate | Perrigo New York Inc | ANDA | Current |
| 45802-122 | loratadine D | loratadine, Pseudoephedrine sulfate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 46122-109 | good neighbor pharmacy loratadine d | Loratadine, Pseudoephedrine | Amerisource Bergen | ANDA | Current |
| 46122-455 | good neighbor pharmacy loratadine d | loratadine, Pseudoephedrine sulfate | Amerisource Bergen | ANDA | Current |
| 46122-455 | good neighbor pharmacy loratadine d | loratadine, Pseudoephedrine sulfate | Amerisource Bergen | ANDA | Current |
| 46122-455 | good neighbor pharmacy loratadine d | loratadine, Pseudoephedrine sulfate | Amerisource Bergen | ANDA | Current |
| 49035-643 | equate allergy and congestion relief | loratadine, pseudoephedrine sulfate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-643 | equate allergy and congestion relief | loratadine, pseudoephedrine sulfate | Wal-Mart Stores Inc | ANDA | Current |
| 49348-183 | sunmark loratadine d | Loratadine, Pseudoephedrine | McKesson | ANDA | Current |
| 49738-013 | Smart Sense allergy and congestion relief | Loratadine, Pseudoephedrine | Kmart Corporation | ANDA | Current |
| 49738-118 | smart sense allergy and congestion relief d | Loratadine, Pseudoephedrine | Kmart Corporation | ANDA | Current |
| 56062-013 | allergy relief d | Loratadine, Pseudoephedrine | Publix Super Markets Inc | ANDA | Current |
| 56062-013 | allergy relief d | Loratadine, Pseudoephedrine | Publix Super Markets Inc | ANDA | Current |
| 56062-555 | allergy relief d | loratadine, Pseudoephedrine sulfate | Publix Super Markets Inc | ANDA | Current |
| 56062-555 | allergy relief d | loratadine, Pseudoephedrine sulfate | Publix Super Markets Inc | ANDA | Current |
| 56062-555 | allergy relief d | loratadine, Pseudoephedrine sulfate | Publix Super Markets Inc | ANDA | Current |
| 59779-013 | Allergy Relief d 12 | Loratadine, Pseudoephedrine | CVS Pharmacy | ANDA | Current |
| 59779-013 | Allergy Relief d 12 | Loratadine, Pseudoephedrine | CVS Pharmacy | ANDA | Current |
| 62011-0354 | health mart allergy and congestion | loratadine, Pseudoephedrine sulfate | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0354 | health mart allergy and congestion | loratadine, Pseudoephedrine sulfate | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0354 | health mart allergy and congestion | loratadine, Pseudoephedrine sulfate | McKesson | ANDA | Current |
| 62011-0354 | health mart allergy and congestion | loratadine, Pseudoephedrine sulfate | McKesson | ANDA | Current |
| 63629-4790 | Loratadine D | Loratadine, Pseudoephedrine | Bryant Ranch Prepack | ANDA | Current |
| 63981-013 | Kirkland Signature AllerClear D 12 hr | Loratadine, Pseudoephedrine | Costco Wholesale Company | ANDA | Current |
| 63981-013 | Kirkland Signature AllerClear D 12 hr | Loratadine, Pseudoephedrine | Costco Wholesale Company | ANDA | Current |
| 63981-723 | kirkland signature allerclear d 12 hr | loratadine, Pseudoephedrine sulfate | Costco Wholesale Company | ANDA | Current |
| 63981-723 | kirkland signature allerclear d 12 hr | loratadine, Pseudoephedrine sulfate | Costco Wholesale Company | ANDA | Current |
| 63981-723 | kirkland signature allerclear d 12 hr | loratadine, Pseudoephedrine sulfate | Costco Wholesale Company | ANDA | Current |
| 69256-013 | Harris Teeter Allergy and Congestion Relief | Loratadine, Pseudoephedrine | Harris Teeter, LLC | ANDA | Current |
| 69256-257 | Harris Teeter Allergy and Congestion Relief | loratadine, Pseudoephedrine sulfate | Harris Teeter, LLC | ANDA | Current |