Application 075679
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOPROFEN | KETOPROFEN | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | Yes |
| 002 | KETOPROFEN | KETOPROFEN | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 003 | KETOPROFEN | KETOPROFEN | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075679-001 | KETOPROFEN | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | |
| A075679-002 | KETOPROFEN | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | ||
| A075679-003 | KETOPROFEN | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075679-003 | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075679-001 | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2002-02-20 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A075679-002 | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | 2002-02-20 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Ketoprofen | KETOPROFEN | Mylan Pharmaceuticals Inc. | 198a4140-f4c0-4478-9157-ee1d68d0bb96 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 075679 ANDA075679 0378-8200 |
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 |
|---|---|---|---|---|---|
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8762 | ORIG | 2003-04-10 |