Active ingredient
Theophylline
51 finished FDA listings contain Theophylline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- THEOPHYLLINE, THEOPHYLLINE ANHYDROUS
- Dosage forms
- Capsule, Extended Release, Solution, Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 26
- Strengths listed
- 100 mg/1 · 200 mg/1 · 300 mg/1 · 400 mg/1 · 450 mg/1 · 600 mg/1 · 80 mg/15ml
- Brand names in FDA listings
- Theo-24, Theophylline (Anhydrous)
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10438
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 087943 | ENDO OPERATIONS | 1983-08-22 | 1 |
| ANDA 089763 | HERITAGE PHARMA AVET | 1990-04-30 | 3 |
| ANDA 081236 | HERITAGE PHARMA AVET | 1992-11-09 | 1 |
| ANDA 040560 | MPP PHARMA | 2006-04-21 | 6 |
| ANDA 090355 | GLENMARK PHARMS LTD | 2010-07-13 | 2 |
| ANDA 090430 | ALEMBIC | 2010-10-27 | 4 |
| ANDA 091156 | CHARTWELL MOLECULAR | 2011-04-13 | 2 |
| ANDA 091586 | TRIS PHARMA INC | 2012-06-15 | 4 |
| ANDA 206344 | PHARM ASSOC | 2016-12-16 | 2 |
| ANDA 212184 | GLENMARK PHARMS LTD | 2021-06-03 | 2 |
| ANDA 216961 | TEVA PHARMS INC | 2022-10-12 | 2 |
| ANDA 214950 | VELZEN PHARMA PVT | 2023-01-30 | 2 |
| ANDA 216276 | AMNEAL | 2023-03-20 | 2 |
| ANDA 216300 | BIONPHARMA | 2023-04-26 | 1 |
| ANDA 217422 | ANNORA PHARMA | 2023-09-08 | 2 |
| ANDA 214806 | HARMAN FINOCHEM | 2023-10-24 | 2 |
| ANDA 218063 | ZYDUS LIFESCIENCES | 2024-05-21 | 4 |
| ANDA 215312 | STRIDES PHARMA | 2024-09-05 | 4 |
| ANDA 218401 | AJANTA PHARMA LTD | 2025-01-13 | 2 |
Official labeling on DailyMed
- THEOPHYLLINE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] · version 7 · 2026-07-31
- THEOPHYLLINE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] · version 7 · 2026-07-31
- THEOPHYLLINE TABLET, EXTENDED RELEASE [TEVA PHARMACEUTICALS, INC.] · version 4 · 2026-07-15
- THEOPHYLLINE TABLET, EXTENDED RELEASE [STRIDES PHARMA SCIENCE LIMITED] · version 5 · 2026-06-08
- THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 5 · 2026-06-01
- THEOPHYLLINE SOLUTION [CHARTWELL RX, LLC] · version 4 · 2026-02-09
- THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] · version 10 · 2026-01-30
- THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] · version 3 · 2026-01-30
- THEOPHYLLINE TABLET, EXTENDED RELEASE [AVKARE] · version 2 · 2026-01-21
- THEOPHYLLINE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.] · version 5 · 2026-01-12
- THEOPHYLLINE TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC] · version 2 · 2025-12-12
- THEOPHYLLINE SOLUTION [ATLANTIC BIOLOGICALS CORP.] · version 5 · 2025-12-08
Showing the 12 most recent of 28 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.