Application 209093

Type: ANDA
Sponsor: AMNEAL 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 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	TE codes	Approval date
A209093-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17
A209093-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17
A209093-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209093-001	AB
A209093-002	AB
A209093-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209093-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209093-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209093-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-05-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209093-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209093-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209093-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209093-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209093-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209093-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209093-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209093-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209093-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209093-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209093-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209093-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209093-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209093-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209093-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209093-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209093-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209093-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209093-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209093-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209093-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209093-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209093-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209093-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209093-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209093-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209093-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR	AvKARE	c61bb5af-558f-4b32-b34d-8fdae480443c	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209093 application number: ANDA209093 ndc (product): 42291-666 ndc (product): 42291-664
Oseltamivir Phosphate	OSELTAMIVIR	Amneal Pharmaceuticals NY LLC	8ca926e0-4c3c-473f-9cd0-ff38032d6963	2023-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209093 application number: ANDA209093 ndc (product): 60219-1264 ndc (product): 60219-1265 ndc (product): 60219-1266
Oseltamivir Phosphate	OSELTAMIVIR	Amneal Pharmaceuticals NY LLC	d306e22c-0cb8-46cb-9a40-8194a2bc9e85	2022-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209093 application number: ANDA209093 ndc (product): 69238-1264 ndc (product): 69238-1266 ndc (product): 69238-1265

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-664	Oseltamivir Phosphate	Oseltamivir	AvKARE, Inc.	ANDA	Current
42291-664	Oseltamivir Phosphate	Oseltamivir	AvKARE, Inc.	ANDA	Current
42291-664	Oseltamivir Phosphate	Oseltamivir	AvKARE	ANDA	Current
42291-664	Oseltamivir Phosphate	Oseltamivir	AvKARE	ANDA	Current
42291-666	Oseltamivir Phosphate	Oseltamivir	AvKARE, Inc.	ANDA	Current
42291-666	Oseltamivir Phosphate	Oseltamivir	AvKARE, Inc.	ANDA	Current
42291-666	Oseltamivir Phosphate	Oseltamivir	AvKARE	ANDA	Current
42291-666	Oseltamivir Phosphate	Oseltamivir	AvKARE	ANDA	Current
50090-4650	Oseltamivir Phosphate	Oseltamivir	A-S Medication Solutions	ANDA	Current
50090-4650	Oseltamivir Phosphate	Oseltamivir	A-S Medication Solutions	ANDA	Current
60219-1264	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1265	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1266	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1264	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1264	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1264	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1264	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1264	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1264	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1265	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1265	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1265	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1265	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1265	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1265	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1266	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1266	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1266	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1266	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1266	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1266	Oseltamivir Phosphate	Oseltamivir	Amneal Pharmaceuticals LLC	ANDA	Current