Application 210157

Type: ANDA
Sponsor: MYLAN

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	Approval date
A210157-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21
A210157-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21
A210157-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21

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 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210157-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	2021-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210157-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210157-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	2021-01-21	`301d65b070ca…`

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	Strides Pharma Science Limited	f26154bd-374c-44a8-983a-b2724a591653	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Leading Pharma, LLC	ef093e4d-5b1a-463f-a1a3-b795a4387a81	2026-08-24	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	2026-08-10	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	2026-08-10	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	2026-08-07	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	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.