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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.

ApplicationSponsorOriginal approvalListings
NDA 021087ROCHE1999-10-272
NDA 021246ROCHE2000-12-141
ANDA 202595NATCO2016-08-034
ANDA 208578ZYDUS PHARMS2017-02-248
ANDA 209093AMNEAL PHARMS2017-05-178
ANDA 207211MACLEODS PHARMS2017-09-147
ANDA 209113ZYDUS PHARMS2017-09-143
ANDA 208823ALVOGEN2017-10-312
ANDA 208348LUPIN2018-01-098
ANDA 208347LUPIN2018-02-204
ANDA 209438HETERO LABS LTD III2018-02-2314
ANDA 210186AMNEAL PHARMS NY2018-02-272
ANDA 209421STRIDES PHARMA2018-06-0810
ANDA 211125TEVA PHARMS USA2019-02-272
ANDA 211823ALEMBIC2019-06-246
ANDA 212739SUNSHINE2020-03-046
ANDA 212544MSN2020-05-206
ANDA 212784AJANTA PHARMA LTD2020-05-273
ANDA 212858INVAGEN PHARMS2021-08-302
ANDA 215208EPIC PHARMA LLC2021-10-013
ANDA 213594SUNSHINE2022-01-053
ANDA 211894STRIDES PHARMA2022-01-131
ANDA 214949LEADING2022-02-281
ANDA 209590HETERO LABS LTD V2022-03-281
ANDA 215313MSN2022-05-021
ANDA 215538EPIC PHARMA LLC2023-02-141
ANDA 217467INVAGEN PHARMS2023-10-033
ANDA 218009ZHEJIANG POLY PHARM2023-11-244
ANDA 218565LAURUS2024-05-013
ANDA 218131AUROBINDO PHARMA LTD2024-05-101
ANDA 217303PHARMOBEDIENT2024-07-021
ANDA 217274SHANDONG2025-07-093
ANDA 218307ALEMBIC2026-06-252

Official labeling on DailyMed

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.