Active ingredient
Oseltamivir
126 finished FDA listings contain Oseltamivir as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- OSELTAMIVIR PHOSPHATE
- Dosage forms
- Capsule, For Suspension, Powder, For Suspension, Suspension
- Routes
- Oral
- Manufacturers / labelers
- 37
- Strengths listed
- 30 mg/1 · 45 mg/1 · 6 mg/ml · 75 mg/1
- Brand names in FDA listings
- Oseltamivir, Oseltamivir Phosphate, Oseltamivir Phosphate For Oral Suspension, Tamiflu
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 260101
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 |
|---|---|---|---|
| NDA 021087 | ROCHE | 1999-10-27 | 2 |
| NDA 021246 | ROCHE | 2000-12-14 | 1 |
| ANDA 202595 | NATCO | 2016-08-03 | 4 |
| ANDA 208578 | ZYDUS PHARMS | 2017-02-24 | 8 |
| ANDA 209093 | AMNEAL PHARMS | 2017-05-17 | 8 |
| ANDA 207211 | MACLEODS PHARMS | 2017-09-14 | 7 |
| ANDA 209113 | ZYDUS PHARMS | 2017-09-14 | 3 |
| ANDA 208823 | ALVOGEN | 2017-10-31 | 2 |
| ANDA 208348 | LUPIN | 2018-01-09 | 8 |
| ANDA 208347 | LUPIN | 2018-02-20 | 4 |
| ANDA 209438 | HETERO LABS LTD III | 2018-02-23 | 14 |
| ANDA 210186 | AMNEAL PHARMS NY | 2018-02-27 | 2 |
| ANDA 209421 | STRIDES PHARMA | 2018-06-08 | 10 |
| ANDA 211125 | TEVA PHARMS USA | 2019-02-27 | 2 |
| ANDA 211823 | ALEMBIC | 2019-06-24 | 6 |
| ANDA 212739 | SUNSHINE | 2020-03-04 | 6 |
| ANDA 212544 | MSN | 2020-05-20 | 6 |
| ANDA 212784 | AJANTA PHARMA LTD | 2020-05-27 | 3 |
| ANDA 212858 | INVAGEN PHARMS | 2021-08-30 | 2 |
| ANDA 215208 | EPIC PHARMA LLC | 2021-10-01 | 3 |
| ANDA 213594 | SUNSHINE | 2022-01-05 | 3 |
| ANDA 211894 | STRIDES PHARMA | 2022-01-13 | 1 |
| ANDA 214949 | LEADING | 2022-02-28 | 1 |
| ANDA 209590 | HETERO LABS LTD V | 2022-03-28 | 1 |
| ANDA 215313 | MSN | 2022-05-02 | 1 |
| ANDA 215538 | EPIC PHARMA LLC | 2023-02-14 | 1 |
| ANDA 217467 | INVAGEN PHARMS | 2023-10-03 | 3 |
| ANDA 218009 | ZHEJIANG POLY PHARM | 2023-11-24 | 4 |
| ANDA 218565 | LAURUS | 2024-05-01 | 3 |
| ANDA 218131 | AUROBINDO PHARMA LTD | 2024-05-10 | 1 |
| ANDA 217303 | PHARMOBEDIENT | 2024-07-02 | 1 |
| ANDA 217274 | SHANDONG | 2025-07-09 | 3 |
| ANDA 218307 | ALEMBIC | 2026-06-25 | 2 |
Official labeling on DailyMed
- OSELTAMIVIR PHOSPHATE CAPSULE [STRIDES PHARMA SCIENCE LIMITED] · version 10 · 2026-09-10
- OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA, INC.] · version 6 · 2026-09-02
- OSELTAMIVIR PHOSPHATE SUSPENSION [LEADING PHARMA, LLC] · version 10 · 2026-08-25
- OSELTAMIVIR PHOSPHATE FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] · version 7 · 2026-08-12
- OSELTAMIVIR PHOSPHATE CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 5 · 2026-08-12
- OSELTAMIVIR PHOSPHATE CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 5 · 2026-08-10
- OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] · version 3 · 2026-08-10
- OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED] · version 8 · 2026-08-03
- OSELTAMIVIR PHOSPHATE CAPSULE [A-S MEDICATION SOLUTIONS] · version 1 · 2026-07-24
- OSELTAMIVIR PHOSPHATE CAPSULE [ALVOGEN INC.] · version 21 · 2026-07-20
- OSELTAMIVIR PHOSPHATE FOR SUSPENSION [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2026-07-06
- OSELTAMIVIR PHOSPHATE FOR SUSPENSION [ALEMBIC PHARMACEUTICALS INC.] · version 6 · 2026-06-30
Showing the 12 most recent of 80 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.