Application 019083
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | INJECTABLE;INJECTION | 40MG/100ML | No | No |
| 002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | INJECTABLE;INJECTION | 80MG/100ML | No | No |
| 003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | INJECTABLE;INJECTION | 160MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | ||
| N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | ||
| N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019083-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019083-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019083-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | 1984-11-07 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| Theophylline | THEOPHYLLINE | Harman Finochem Limited | 098db8bb-fa9a-4577-b7d9-86caaefc168a | 2024-04-27 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Bionpharma Inc., | 63517422-45a0-4e78-8505-eca054068ee9 | 2023-10-12 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Camber Pharmaceuticals, Inc. | bf320619-c53b-49a7-97b5-cd0c075a9f75 | 2023-09-20 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Alembic Pharmaceuticals Limited | 31f3c720-1597-4d43-9296-33017b90b15f | 2023-01-11 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Teva Pharmaceuticals, Inc. | 25eabefa-518b-4030-9b72-01ac8b3deba9 | 2022-04-01 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Alembic Pharmaceuticals Inc. | 77e849b8-900b-4f0d-ac5c-1391abcd5721 | 2021-10-01 | Warnings, Adverse reactions | THEOPHYLLINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.