Home Applications 021246 Application 021246
Type NDA
Sponsor ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAMIFLU OSELTAMIVIR PHOSPHATE FOR SUSPENSION;ORAL EQ 12MG BASE/ML No No 002 TAMIFLU OSELTAMIVIR PHOSPHATE FOR SUSPENSION;ORAL EQ 6MG BASE/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021246-001 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 N021246-002 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021246-002 AB
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.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021246-001 TAMIFLU EQ 12MG BASE/ML FOR SUSPENSION / ORAL 2000-12-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021246-002 TAMIFLU EQ 6MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2011-03-21 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book exclusivity history# 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0004-0822 Tamiflu Oseltamivir Phosphate Genentech, Inc. NDA Current 0004-0822 Tamiflu Oseltamivir Phosphate Genentech, Inc. NDA Current 0004-0822 Tamiflu Oseltamivir Phosphate Genentech, Inc. NDA Current 0004-0822 Tamiflu Oseltamivir Phosphate Genentech, Inc. NDA Current 0004-0822 Tamiflu Oseltamivir Phosphate Genentech, Inc. NDA Current 42254-092 Tamiflu Oseltamivir Phosphate Rebel Distributors Corp NDA Current 50090-1244 Tamiflu Oseltamivir Phosphate A-S Medication Solutions NDA Current 50090-1244 Tamiflu Oseltamivir Phosphate A-S Medication Solutions NDA Current 55045-3198 Tamiflu oseltamivir phosphate Dispensing Solutions, Inc. NDA Current