Application 081034
- Type
- ANDA
- Sponsor
- AUXILIUM PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THEO-24 | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 400MG | No | Yes |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | ea99ee380514… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Theo-24 | THEOPHYLLINE ANHYDROUS | ENDO USA, Inc. | 7a108fa0-c230-475f-be93-6f864b98a410 | 2024-07-08 | Warnings, Adverse reactions | 081034 ANDA081034 52244-400 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52244-400 | Theo-24 | theophylline anhydrous | Endo Pharmaceuticals, Inc. | ANDA | Current |