Application 208578

Type: ANDA
Sponsor: NESHER PHARMS

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	Approval date
A208578-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24
A208578-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24
A208578-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208578-001	AB
A208578-002	AB
A208578-003	AB

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 4 · 126 observed 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
2026-08-18 06:07:40	2026-07	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208578-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208578-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208578-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-02-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208578-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208578-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208578-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208578-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208578-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208578-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208578-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208578-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208578-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208578-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208578-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208578-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208578-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208578-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208578-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208578-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208578-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208578-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208578-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208578-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208578-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208578-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208578-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208578-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208578-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208578-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208578-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208578-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208578-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208578-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208578-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208578-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208578-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208578-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208578-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208578-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208578-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208578-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208578-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208578-001	AB	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	9dac3ba2-b667-4081-9395-8db45d38ceac	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208578 application number: ANDA208578
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Redpharm Drug	2fbd0c56-82bf-f0fa-e063-6294a90a9f2f	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208578 application number: ANDA208578
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Lifesciences Limited	58118069-cb24-4fa3-92d7-cabdc1b027f2	2024-12-03		Exact identifier application applno (ANDA): 208578 application number: ANDA208578 ndc (product): 70771-1710 ndc (product): 70771-1712 ndc (product): 70771-1711
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals USA Inc.	0e666061-1bfd-48cd-896b-ded8298a1847	2022-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208578 application number: ANDA208578 ndc (product): 70710-1010 ndc (product): 70710-1008 ndc (product): 70710-1009

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3718	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	ANDA	Current
50090-3718	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	ANDA	Current
50090-3718	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	ANDA	Current
53002-1387	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1387	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1710	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1710	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-3385	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7070	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0764	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	REMEDYREPACK INC.	ANDA	Current
70518-0764	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	REMEDYREPACK INC.	ANDA	Current
70710-1008	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1008	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1008	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1008	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1008	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1009	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1009	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1009	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1009	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1009	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1010	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1010	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1010	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1010	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1010	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1710	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Cadila Healthcare Limited	ANDA	Current
70771-1710	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Lifesciences Limited	ANDA	Current
70771-1711	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Cadila Healthcare Limited	ANDA	Current
70771-1711	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Lifesciences Limited	ANDA	Current
70771-1712	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Cadila Healthcare Limited	ANDA	Current
70771-1712	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	Zydus Lifesciences Limited	ANDA	Current