Application 209421

Type: ANDA
Sponsor: STRIDES PHARMA

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
A209421-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08
A209421-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08
A209421-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209421-001	AB
A209421-002	AB
A209421-003	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	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209421-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209421-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209421-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-06-08	`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	A209421-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209421-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209421-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209421-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209421-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209421-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209421-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209421-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209421-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209421-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209421-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209421-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209421-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209421-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209421-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209421-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209421-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209421-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209421-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209421-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209421-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209421-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209421-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209421-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209421-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209421-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Sportpharm LLC	92726a00-4237-49fd-9e29-5d4f5f999874	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Preferred Pharmaceuticals Inc.	89a3539b-a067-4073-b7a0-d04e7f130396	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421 ndc (product): 68788-8122
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	91eadf0b-5f04-4f5d-b095-02c5736a3647	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421 ndc (product): 50090-6239
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Asclemed USA, Inc.	78f85d27-9935-4775-b8d7-275e11429b76	2023-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Strides Pharma Science Limited	f26154bd-374c-44a8-983a-b2724a591653	2022-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421 ndc (product): 64380-797 ndc (product): 64380-799 ndc (product): 64380-798
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Proficient Rx LP	de553d49-38c3-4fad-8582-d4d27c3c26b1	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209421 application number: ANDA209421 ndc (product): 71205-397

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4783	Oseltamivir Phosphate	Oseltamivir Phosphate	A-S Medication Solutions	ANDA	Current
50090-6239	Oseltamivir Phosphate	Oseltamivir Phosphate	A-S Medication Solutions	ANDA	Current
53002-4710	Oseltamivir Phosphate	Oseltamivir Phosphate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-5387	Oseltamivir Phosphate	Oseltamivir Phosphate	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-793	Oseltamivir Phosphate	Oseltamivir Phosphate	Quality Care Products, LLC	ANDA	Current
55700-793	Oseltamivir Phosphate	Oseltamivir Phosphate	Quality Care Products, LLC	ANDA	Current
55700-793	Oseltamivir Phosphate	Oseltamivir Phosphate	Quality Care Products, LLC	ANDA	Current
64380-797	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Shasun Limited	ANDA	Current
64380-797	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-797	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-797	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-797	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-797	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-797	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-798	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Shasun Limited	ANDA	Current
64380-798	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-798	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-798	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-798	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-798	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-798	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-799	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Shasun Limited	ANDA	Current
64380-799	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-799	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-799	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-799	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-799	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
64380-799	Oseltamivir Phosphate	Oseltamivir Phosphate	Strides Pharma Science Limited	ANDA	Current
68071-2565	Oseltamivir Phosphate	Oseltamivir Phosphate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68094-050	Oseltamivir Phosphate	Oseltamivir Phosphate	Precision Dose, Inc.	ANDA	Current
68788-7296	Oseltamivir Phosphate	Oseltamivir Phosphate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8122	Oseltamivir Phosphate	Oseltamivir Phosphate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2397	Oseltamivir Phosphate	Oseltamivir Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-2397	Oseltamivir Phosphate	Oseltamivir Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-2397	Oseltamivir Phosphate	Oseltamivir Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-2397	Oseltamivir Phosphate	Oseltamivir Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-2397	Oseltamivir Phosphate	Oseltamivir Phosphate	REMEDYREPACK INC.	ANDA	Current
71205-397	Oseltamivir Phosphate	Oseltamivir Phosphate	Proficient Rx LP	ANDA	Current
71205-397	Oseltamivir Phosphate	Oseltamivir Phosphate	Proficient Rx LP	ANDA	Current