Application 019826
- 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 | Yes | Yes |
| 002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | INJECTABLE;INJECTION | 80MG/100ML | Yes | Yes |
| 003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | INJECTABLE;INJECTION | 160MG/100ML | Yes | Yes |
| 004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | INJECTABLE;INJECTION | 200MG/100ML | No | No |
| 005 | THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | INJECTABLE;INJECTION | 400MG/100ML | No | No |
| 006 | THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | INJECTABLE;INJECTION | 320MG/100ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019826-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 40MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | |
| N019826-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 80MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | |
| N019826-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 160MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | |
| N019826-004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 200MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | ||
| N019826-005 | THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 400MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | ||
| N019826-006 | THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 320MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 |
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 | N019826-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019826-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019826-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019826-004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019826-005 | THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019826-006 | THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | 320MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019826-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019826-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019826-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019826-004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019826-005 | THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019826-006 | THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | 320MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019826-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019826-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019826-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019826-004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019826-005 | THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019826-006 | THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | 320MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019826-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019826-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019826-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019826-004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019826-005 | THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019826-006 | THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | 320MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019826-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019826-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019826-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019826-004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019826-005 | THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019826-006 | THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | 320MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019826-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019826-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019826-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019826-004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019826-005 | THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019826-006 | THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER | 320MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019826-001 | THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | 40MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019826-002 | THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | 80MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019826-003 | THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | 160MG/100ML | INJECTABLE / INJECTION | RLD | 1992-08-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019826-004 | THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1992-08-14 | b8a1b40f171c… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-9554 | Theophylline in Dextrose | Theophylline Anhydrous and Dextrose | B. Braun Medical Inc. | NDA | Current |