Home Applications 021087 Application 021087
Type NDA
Sponsor ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAMIFLU OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE Yes Yes 002 TAMIFLU OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE Yes No 003 TAMIFLU OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021087-001 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 N021087-002 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-07-02 N021087-003 TAMIFLU OSELTAMIVIR PHOSPHATE EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021087-001 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 4 · 126 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 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021087-002 TAMIFLU EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021087-003 TAMIFLU EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL RLD 2007-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL RLD 2007-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL RLD 2007-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL RLD 2007-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021087-002 TAMIFLU EQ 45MG BASE CAPSULE / ORAL AB RLD 2007-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021087-003 TAMIFLU EQ 30MG BASE CAPSULE / ORAL AB RLD 2007-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021087-001 TAMIFLU EQ 75MG BASE CAPSULE / ORAL AB RLD, RS 1999-10-27 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 118 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 42 observed states.
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 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0004-0800 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0800 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0800 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0800 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0800 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0801 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0801 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0801 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0801 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0801 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0802 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0802 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0802 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0802 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 0004-0802 Tamiflu oseltamivir phosphate Genentech, Inc. NDA Current 42254-001 Tamiflu oseltamivir phosphate Rebel Distributors Corp NDA Current 50090-0662 Tamiflu oseltamivir phosphate A-S Medication Solutions NDA Current 50090-0662 Tamiflu oseltamivir phosphate A-S Medication Solutions NDA Current 50090-0662 Tamiflu oseltamivir phosphate A-S Medication Solutions NDA Current 55045-2759 Tamiflu oseltamivir phosphate Dispensing Solutions, Inc. NDA Current 70518-2042 Tamiflu oseltamivir phosphate REMEDYREPACK INC. NDA Current 70518-2042 Tamiflu oseltamivir phosphate REMEDYREPACK INC. NDA Current 70518-2042 Tamiflu oseltamivir phosphate REMEDYREPACK INC. NDA Current 70518-2042 Tamiflu oseltamivir phosphate REMEDYREPACK INC. NDA Current