Home Applications 218565 Application 218565
Type ANDA
Sponsor LAURUS 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 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 A218565-001 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 A218565-002 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 A218565-003 OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 · 48 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 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218565-002 OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE / ORAL AB 2024-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218565-003 OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE / ORAL AB 2024-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218565-001 OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE / ORAL AB 2024-05-01 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 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.