Home Applications 217451 Application 217451
Type ANDA
Sponsor CEDIPROF INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 30MG BASE No No 002 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 45MG BASE No No 003 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE;ORAL EQ 75MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A217451-001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL 2024-12-03 A217451-002 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL 2024-12-03 A217451-003 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL 2024-12-03
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.
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 2026-09-14 22:38:34 2026-08 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL 2024-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL 2024-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL 2024-12-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL 2024-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL 2024-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL 2024-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-12-03 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217451-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL 2024-12-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217451-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL 2024-12-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217451-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL 2024-12-03 a50c72e98297…
Observed Orange Book normalized TE 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 4 of 4 · 74 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE A-S Medication Solutions 73d7fa5a-8304-44b7-9456-58926a265d81 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE Zydus Pharmaceuticals USA Inc. 0e666061-1bfd-48cd-896b-ded8298a1847 2022-12-27 Warnings, Adverse reactions Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE Oseltamivir phosphate OSELTAMIVIR PHOSPHATE Proficient Rx LP cd0236c6-317c-47b1-9185-3253dba4bb37 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE Amneal Pharmaceuticals NY LLC c1a280d0-4ce9-494a-9924-eb5621ce3757 2022-09-30 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE Asclemed USA, Inc. 00be0870-2ebb-46e3-9e98-a8f068ec664a 2022-09-22 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE Proficient Rx LP 1f754ad7-9df0-4121-8051-0a09491be3c7 2022-09-01 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE Proficient Rx LP c754c2f7-7109-4498-aeee-c8ee088dfa98 2022-09-01 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir Phosphate OSELTAMIVIR Amneal Pharmaceuticals NY LLC d306e22c-0cb8-46cb-9a40-8194a2bc9e85 2022-08-30 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE Proficient Rx LP 8d264c73-4dd9-4f7c-8a18-f31195cdd013 2022-08-01 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir phosphate OSELTAMIVIR PHOSPHATE Camber Pharmaceuticals, Inc. 5c959361-8f08-4c65-968f-404a44422133 2022-06-02 Warnings, Adverse reactions Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE oseltamivir phosphate OSELTAMIVIR PHOSPHATE Novadoz Pharmaceuticals LLC 46dda802-32b8-4608-8eae-97e2cfc57472 2022-05-16 Warnings, Adverse reactions Name fallback brand name: oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir phosphate OSELTAMIVIR PHOSPHATE Proficient Rx LP 196c8dee-342b-4627-b060-39b99ed91a41 2022-05-02 Warnings, Adverse reactions Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE Proficient Rx LP de553d49-38c3-4fad-8582-d4d27c3c26b1 2022-05-01 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE Oseltamivir Phosphate OSELTAMIVIR PHOSPHATE Camber Pharmaceuticals, Inc. 2a673aa2-e8f0-4aa4-8782-6fb3067ff108 2018-03-07 Warnings, Adverse reactions Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.