Application 211360
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 220MG;120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 5c6f7cd8ea54… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | VESPYR BRANDS LLC | a973cb82-1e00-4706-8b96-648135ea48a1 | 2026-06-15 | Warnings | 211360 ANDA211360 |
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | Aurohealth LLC | 638a9664-4129-46fd-9ba1-d660a7366c9f | 2025-02-12 | Warnings | 211360 ANDA211360 58602-816 |
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | Aurohealth LLC | 10a8a74b-11d1-490e-87e7-d705fe0e7602 | 2025-01-21 | Warnings | 211360 ANDA211360 58602-832 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 58602-816 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | Naproxen Sodium and Pseudoephedrine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-832 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | Naproxen Sodium and Pseudoephedrine Hydrochloride | Aurohealth LLC | ANDA | Current |