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 2 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tamiflu	OSELTAMIVIR PHOSPHATE	Genentech, Inc.	ee3c9555-60f2-4f82-a760-11983c86e97b	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	MSN LABORATORIES PRIVATE LIMITED	1b7a02ca-ee0e-4853-91e6-71a79f2bc040	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Exelan Pharmaceuticals, Inc.	31c90a2e-9d14-4236-8dc2-b2a862e8cbac	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Aurobindo Pharma Limited	07958a9a-2360-4380-b7da-5371ed80a271	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Zhejiang Poly Pharm. Co., Ltd.	339778ee-0b6f-6d81-e063-6394a90a2d32	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Lupin Pharmaceuticals, Inc.	b428e1f2-0082-4d9f-908e-e3633ea0457b	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Lupin Pharmaceuticals, Inc.	7dd9f7f2-a887-454a-8d3e-761083b840db	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Strides Pharma Science Limited	39255500-0ffd-4d72-abe8-257570b543e7	2025-09-09	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	817f74ca-2b6d-4d29-8dd5-b96921a23b91	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	89a3539b-a067-4073-b7a0-d04e7f130396	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	b1abef84-d074-4872-9193-48a52cbabbd6	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	16fcbcb4-609c-4d4e-a134-013823207dc7	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Ajanta Pharma USA Inc.	c6f78d2d-6452-4af3-83c6-b044d1604bdc	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Macleods Pharmaceuticals Limited	e9307620-36bd-46c2-a8b2-027d3fba87ba	2025-06-18	Warnings, Adverse reactions	Name fallback brand name: oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Teva Pharmaceuticals USA, Inc.	3ea5bf8f-c3fa-4d44-bc3d-b1912374ee4b	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Slate Run Pharmaceuticals, LLC	613c8c4d-e647-4a4b-ac9b-c39aaa781ace	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate for Oral Suspension	OSELTAMIVIR PHOSPHATE	Alvogen Inc.	82df3237-636b-7bf9-3ba0-2b476e74bf4c	2025-02-28	Warnings, Adverse reactions	Name fallback generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Asclemed USA, Inc.	d9902b17-389b-45d4-b02f-67e35b0a5f3e	2025-02-27	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	40312c99-5374-41fa-a687-c70d97445e24	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR ACID	Zydus Lifesciences Limited	7c0923ad-80b0-4134-b44a-754ea599f356	2024-12-09		Name fallback brand name: Oseltamivir Phosphate