Application 206568
- Type
- ANDA
- Sponsor
- HUMANWELL PURACAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBUPROFEN | IBUPROFEN | CAPSULE;ORAL | EQ 200MG FREE ACID AND POTASSIUM SALT | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206568-001 | IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 |
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 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | f41ea6bd6efb… |
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.
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 |
|---|---|---|---|---|---|
| 49035-265 | Ibuprofen minis | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-745 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | Current |
| 49035-745 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-745 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-745 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-749 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-749 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-749 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49738-745 | Ibuprofen | Ibuprofen | SMART SENSE (Kmart) | ANDA | Current |
| 49738-745 | Ibuprofen | Ibuprofen | SMART SENSE (Kmart) | ANDA | Current |
| 49738-745 | Ibuprofen | Ibuprofen | SMART SENSE (Kmart) | ANDA | Current |
| 50594-843 | Ibuprofen minis | Ibuprofen | Big Lots | ANDA | Current |
| 50594-843 | Ibuprofen minis | Ibuprofen | Big Lots | ANDA | Current |
| 50594-843 | Ibuprofen minis | Ibuprofen | Big Lots | ANDA | Current |
| 51013-103 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-103 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-405 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-405 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-410 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-410 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-421 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-421 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-422 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-422 | Ibuprofen | Ibuprofen | PuraCap Pharmaceutical LLC | ANDA | Current |
| 51013-429 | Ibuprofen | Ibuprofen | PURACAP PHARMACEUTICAL LLC | ANDA | Current |
| 51013-429 | Ibuprofen | Ibuprofen | PURACAP PHARMACEUTICAL LLC | ANDA | Current |
| 53345-014 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-014 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-014 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-014 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-014 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-014 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-039 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-039 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-039 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-039 | Ibuprofen | Ibuprofen | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 53345-050 | Ibuprofen mini | Ibuprofen mini | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | ANDA | Current |
| 55301-745 | Ibuprofen | Ibuprofen | AAFES/Your Military Exchanges | ANDA | Current |
| 55301-745 | Ibuprofen | Ibuprofen | AAFES/Your Military Exchanges | ANDA | Current |
| 55301-745 | Ibuprofen | Ibuprofen | AAFES/Your Military Exchanges | ANDA | Current |
| 55301-745 | Ibuprofen | Ibuprofen | AAFES/Your Military Exchanges | ANDA | Current |
| 55301-745 | Ibuprofen | Ibuprofen | AAFES/Your Military Exchanges | ANDA | Current |
| 55319-745 | Ibuprofen | Ibuprofen | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-745 | Ibuprofen | Ibuprofen | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-843 | Ibuprofen minis | Ibuprofen | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-843 | Ibuprofen minis | Ibuprofen | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-843 | Ibuprofen minis | Ibuprofen | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55910-741 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-741 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-741 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-741 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-845 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-845 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-845 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-849 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-849 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-849 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-849 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-953 | Ibuprofen minis | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-953 | Ibuprofen minis | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-953 | Ibuprofen minis | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-953 | Ibuprofen minis | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 59726-745 | Ibuprofen | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-745 | Ibuprofen | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-745 | Ibuprofen | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-745 | Ibuprofen | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-745 | Ibuprofen | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-843 | Ibuprofen minis | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-843 | Ibuprofen minis | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-843 | Ibuprofen minis | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-843 | Ibuprofen minis | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 62011-0368 | Ibuprofen | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0368 | Ibuprofen | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0368 | Ibuprofen | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0368 | Ibuprofen | Ibuprofen | McKesson (Health Mart) | ANDA | Current |
| 62011-0399 | Ibuprofen Minis | Ibuprofen | McKesson (Health Mart) | ANDA | Current |
| 62011-0399 | Ibuprofen Minis | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0399 | Ibuprofen Minis | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0399 | Ibuprofen Minis | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 63868-239 | Ibuprofen | Ibuprofen | Chain Drug Marketing Association Inc. | ANDA | Current |