Application 075153
- Type
- ANDA
- Sponsor
- L PERRIGO CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 |
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 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1999-02-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075153-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1999-02-26 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|
| 0113-0054 | Good Sense Suphedrine | Pseudoephedrine Hydrochloride | L. Perrigo Company | ANDA | Current |
| 0113-0054 | Good Sense Suphedrine | Pseudoephedrine Hydrochloride | L. Perrigo Company | ANDA | Current |
| 0113-2017 | sinus 12 hour | Pseudoephedrine HCl | L. Perrigo Company | ANDA | Current |
| 0113-2017 | sinus 12 hour | Pseudoephedrine HCl | L. Perrigo Company | ANDA | Current |
| 0113-2017 | sinus 12 hour | Pseudoephedrine HCl | L. Perrigo Company | ANDA | Current |
| 0113-2054 | 12 hour decongestant | Pseudoephedrine Hydrochloride | L. Perrigo Company | ANDA | Current |
| 0363-0061 | walphed d | Pseudoephedrine HCl | Walgreen Company | ANDA | Current |
| 0363-0061 | walphed d | Pseudoephedrine HCl | Walgreen Company | ANDA | Current |
| 0363-3301 | Nasal Decongestant D | Pseudoephedrine Hydrochloride | Walgreen Company | ANDA | Current |
| 0904-6754 | SudoGest 12 Hour | Pseudoephedrine HCl | Major Pharmaceuticals | ANDA | Current |
| 0904-6754 | SudoGest 12 Hour | Pseudoephedrine HCl | Major Pharmaceuticals | ANDA | Current |
| 0904-6754 | SudoGest 12 Hour | Pseudoephedrine HCl | Major Pharmaceuticals | ANDA | Current |
| 11673-112 | up and up sinus 12 hour | Pseudoephedrine HCl | Target Corporation | ANDA | Current |
| 11822-0650 | sinus pressure and congestion relief | Pseudoephedrine HCl | Rite Aid Corporation | ANDA | Current |
| 11822-0650 | sinus pressure and congestion relief | Pseudoephedrine HCl | Rite Aid Corporation | ANDA | Current |
| 11822-0650 | sinus pressure and congestion relief | Pseudoephedrine HCl | Rite Aid Corporation | ANDA | Current |
| 24385-054 | good neighbor pharmacy nasal decongestant | Pseudoephedrine Hydrochloride | Amerisource Bergen | ANDA | Current |
| 24385-054 | good neighbor pharmacy nasal decongestant | Pseudoephedrine Hydrochloride | Amerisource Bergen | ANDA | Current |
| 30142-054 | 12 hour decongestant | Pseudoephedrine Hydrochloride | Kroger Company | ANDA | Current |
| 30142-054 | 12 hour decongestant | Pseudoephedrine Hydrochloride | Kroger Company | ANDA | Current |
| 30142-559 | sinus | Pseudoephedrine HCl | Kroger Company | ANDA | Current |
| 36800-054 | topcare 12 hour decongestant | Pseudoephedrine Hydrochloride | Topco Associates LLC | ANDA | Current |
| 36800-054 | topcare 12 hour decongestant | Pseudoephedrine Hydrochloride | Topco Associates LLC | ANDA | Current |
| 36800-054 | topcare 12 hour decongestant | Pseudoephedrine Hydrochloride | Topco Associates LLC | ANDA | Current |
| 37012-054 | Nasal Decongestant | Pseudoephedrine HCl | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37012-054 | Nasal Decongestant | Pseudoephedrine HCl | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37205-446 | Leader 12 Hour Nasal Decongestant | Pseudoephedrine Hydrochloride | Cardinal Health | ANDA | Current |
| 41163-054 | Equaline 12 Hour Decongestant | Pseudoephedrine Hydrochloride | Supervalu Inc | ANDA | Current |
| 41163-054 | Equaline 12 Hour Decongestant | Pseudoephedrine Hydrochloride | Supervalu Inc | ANDA | Current |
| 41190-054 | ShopRite Nasal Decongestant | Pseudoephedrine HCl | Wakefern Food Corporation | ANDA | Current |
| 41190-054 | ShopRite Nasal Decongestant | Pseudoephedrine HCl | Wakefern Food Corporation | ANDA | Current |
| 41190-054 | ShopRite Nasal Decongestant | Pseudoephedrine HCl | Wakefern Food Corporation | ANDA | Current |
| 41250-054 | 12 hour decongestant | Pseudoephedrine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-054 | 12 hour decongestant | Pseudoephedrine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-809 | nasal decongestant | pseudoephedrine hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-809 | nasal decongestant | pseudoephedrine hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41520-054 | careone suphedrine 12 hour relief | Pseudoephedrine Hydrochloride | American Sales Company | ANDA | Current |
| 41520-429 | CareOne Nasal and Sinus Decongestant | Pseudoephedrine HCl | American Sales Company | ANDA | Current |
| 41520-429 | CareOne Nasal and Sinus Decongestant | Pseudoephedrine HCl | American Sales Company | ANDA | Current |
| 42254-359 | nasal decongestant | Pseudoephedrine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 42507-054 | nasal decongestant | Pseudoephedrine Hydrochloride | HyVee Inc | ANDA | Current |
| 45802-107 | pseudoephedrine hydrochloride | Pseudoephedrine HCl | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-107 | pseudoephedrine hydrochloride | Pseudoephedrine HCl | Perrigo New York Inc | ANDA | Current |
| 45802-107 | pseudoephedrine hydrochloride | Pseudoephedrine HCl | Perrigo New York Inc | ANDA | Current |
| 49035-508 | equate sinus 12 hour | pseudoephedrine hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49348-361 | Sunmark Sinus | Pseudoephedrine Hydrochloride | McKesson | ANDA | Current |
| 49738-009 | smart sense sinus 12 hour | Pseudoephedrine HCl | Kmart Corporation | ANDA | Current |
| 49738-054 | smart sense 12 hour decongestant | Pseudoephedrine Hydrochloride | Kmart Corporation | ANDA | Current |
| 50090-3287 | SUDAFED 12 HOUR | Pseudoephedrine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3287 | SUDAFED 12 HOUR | Pseudoephedrine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4629 | Sudafed Sinus Congestion 12 Hour | Pseudoephedrine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4629 | Sudafed Sinus Congestion 12 Hour | Pseudoephedrine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50580-242 | Sudafed Sinus Congestion 12 Hour | Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-242 | Sudafed Sinus Congestion 12 Hour | Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-342 | SUDAFED 12 HOUR | Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 55316-054 | Healthy Accents 12 Hour Nasal Decongestant | Pseudoephedrine Hydrochloride | DZA Brands LLC | ANDA | Current |
| 59779-703 | 12 Hour Nasal Decongestant | Pseudoephedrine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-703 | 12 Hour Nasal Decongestant | Pseudoephedrine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 62011-0087 | Health Mart nasal decongestant | Pseudoephedrine Hydrochloride | McKesson | ANDA | Current |
| 69256-054 | Harris Teeter Sinus 12 Hour | Pseudoephedrine HCl | Harris Teeter, LLC | ANDA | Current |
| 69256-054 | Harris Teeter Sinus 12 Hour | Pseudoephedrine HCl | Harris Teeter, LLC | ANDA | Current |
| 69256-054 | Harris Teeter Sinus 12 Hour | Pseudoephedrine HCl | Harris Teeter, LLC | ANDA | Current |
| 70000-0475 | leader 12 hour nasal decongestant | Pseudoephedrine Hydrochloride | Cardinal Health | ANDA | Current |
| 70000-0475 | leader 12 hour nasal decongestant | Pseudoephedrine Hydrochloride | Cardinal Health | ANDA | Current |
| 70000-0475 | leader 12 hour nasal decongestant | Pseudoephedrine Hydrochloride | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70518-1618 | pseudoephedrine hydrochloride | Pseudoephedrine HCl | REMEDYREPACK INC. | ANDA | Current |
| 70518-1618 | pseudoephedrine hydrochloride | Pseudoephedrine HCl | REMEDYREPACK INC. | ANDA | Current |
| 70518-1618 | pseudoephedrine hydrochloride | Pseudoephedrine HCl | REMEDYREPACK INC. | ANDA | Current |
| 70518-1618 | pseudoephedrine hydrochloride | Pseudoephedrine HCl | REMEDYREPACK INC. | ANDA | Current |
| 70518-1618 | pseudoephedrine hydrochloride | Pseudoephedrine HCl | REMEDYREPACK INC. | ANDA | Current |
| 70518-2654 | Sudafed Sinus Congestion 12 Hour | Pseudoephedrine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2654 | Sudafed Sinus Congestion 12 Hour | Pseudoephedrine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 80159-302 | Picnic Nasal Decongestant | Pseudoephedrine HCl | 30M One, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8540 | ORIG | 1999-02-26 |