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 1.

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	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	Approval date	Source SHA-256
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217451-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217451-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217451-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217451-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217451-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217451-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217451-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217451-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217451-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217451-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217451-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217451-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217451-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217451-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217451-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217451-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217451-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217451-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217451-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217451-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217451-003	AB	1	`2680178bc6a6…`

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 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	e1bec65b-4292-4110-a840-aa48053b5448	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Alvogen Inc.	809f859e-0852-80d3-1a67-da87ed399c15	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Alembic Pharmaceuticals Inc.	379f59fe-22d9-4bac-b9b5-31fdaebbd923	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir	OSELTAMIVIR PHOSPHATE	Laurus Labs Limited	927cba3a-62cf-4e9f-9871-92835927ea46	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	REMEDYREPACK INC.	ad765459-e0d2-418e-8bae-8f6d16dfc1d8	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Shandong New Time Pharmaceutical Co., Ltd.	61b673d9-4787-4bc8-bf9e-2cfef0326911	2026-06-07	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	HEC Pharm USA Inc.	4dd9214a-6b7f-efe9-e063-6294a90ac4fb	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Sportpharm LLC	a8a40f98-f6bd-4ef0-af03-93ed0f473c10	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Alembic Pharmaceuticals Limited	a70d9914-078f-4b4d-a1be-04669f7d0878	2026-03-22	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	REMEDYREPACK INC.	ad90fe42-8d52-403e-9b07-b8536fbf335a	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Sportpharm LLC	92726a00-4237-49fd-9e29-5d4f5f999874	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Novadoz Pharmaceuticals LLC	c456f293-daf7-46b1-bffc-5ca234adbb70	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	NuCare Pharmaceuticals, Inc.	497adf7b-9bdc-314e-e063-6394a90a63be	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	9dac3ba2-b667-4081-9395-8db45d38ceac	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	AvKARE	7d8ce967-8037-9fd5-e053-2991aa0a015f	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR	AvKARE	c61bb5af-558f-4b32-b34d-8fdae480443c	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Redpharm Drug	2fbd0c56-82bf-f0fa-e063-6294a90a9f2f	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Redpharm Drug	2fd237e8-7ac9-f473-e063-6294a90aadfc	2025-12-27	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Redpharm Drug	2fd1d9f7-a4e0-7fda-e063-6294a90ad425	2025-12-25	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate for Oral Suspension	OSELTAMIVIR PHOSPHATE	Oryza Pharmaceuticals Inc.	11cf45d4-0e6c-4408-bbe6-5ed94468cf2e	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: OSELTAMIVIR PHOSPHATE