Application 207211

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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
A207211-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14
A207211-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14
A207211-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207211-001	AB
A207211-002	AB
A207211-003	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	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207211-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2017-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207211-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207211-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2017-09-14	`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	A207211-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207211-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207211-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207211-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207211-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207211-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207211-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207211-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207211-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207211-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207211-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207211-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207211-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207211-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207211-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207211-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207211-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207211-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207211-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207211-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207211-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207211-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207211-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207211-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207211-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207211-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207211-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207211-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207211-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207211-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207211-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207211-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207211-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207211-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207211-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207211-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207211-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207211-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207211-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207211-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Macleods Pharmaceuticals Limited	e9307620-36bd-46c2-a8b2-027d3fba87ba	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207211 application number: ANDA207211 ndc (product): 33342-258 ndc (product): 33342-257 ndc (product): 33342-256
oseltamavir phosphate	OSELTAMAVIR PHOSPHATE	NuCare Pharmaceuticals,Inc.	80511c6f-88b9-62d3-e053-2991aa0ab936	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207211 application number: ANDA207211 ndc (product): 68071-4739
oseltamavir phosphate	OSELTAMAVIR PHOSPHATE	NuCare Pharmaceuticals, Inc.	28ddaeb7-5903-4b59-e063-6294a90a2bcd	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207211 application number: ANDA207211
oseltamavir phosphate	OSELTAMAVIR PHOSPHATE	Proficient Rx LP	09e119eb-a8fa-4635-96a7-1b134593cdca	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207211 application number: ANDA207211 ndc (product): 71205-107
oseltamavir phosphate	OSELTAMAVIR PHOSPHATE	Proficient Rx LP	ccdb124d-fd56-409a-8615-ae0f675cd8e4	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207211 application number: ANDA207211 ndc (product): 71205-417

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-256	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-256	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-256	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-256	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-257	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-257	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-257	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-257	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-258	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-258	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-258	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-258	oseltamavir phosphate	oseltamavir phosphate	Macleods Pharmaceuticals Limited	ANDA	Current
50090-4159	Oseltamivir phosphate	oseltamavir phosphate	A-S Medication Solutions	ANDA	Current
53002-3387	oseltamavir phosphate	oseltamavir phosphate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3387	oseltamavir phosphate	oseltamavir phosphate	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-4739	oseltamavir phosphate	oseltamavir phosphate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4739	oseltamavir phosphate	oseltamavir phosphate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4739	oseltamavir phosphate	oseltamavir phosphate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7106	oseltamavir phosphate	oseltamavir phosphate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7106	oseltamavir phosphate	oseltamavir phosphate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7106	oseltamavir phosphate	oseltamavir phosphate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1727	oseltamavir phosphate	oseltamavir phosphate	REMEDYREPACK INC.	ANDA	Current
70518-1727	oseltamavir phosphate	oseltamavir phosphate	REMEDYREPACK INC.	ANDA	Current
70518-1727	oseltamavir phosphate	oseltamavir phosphate	REMEDYREPACK INC.	ANDA	Current
70518-1727	oseltamavir phosphate	oseltamavir phosphate	REMEDYREPACK INC.	ANDA	Current
71205-107	oseltamavir phosphate	oseltamavir phosphate	Proficient Rx LP	ANDA	Current
71205-107	oseltamavir phosphate	oseltamavir phosphate	Proficient Rx LP	ANDA	Current
71205-107	oseltamavir phosphate	oseltamavir phosphate	Proficient Rx LP	ANDA	Current
71205-107	oseltamavir phosphate	oseltamavir phosphate	Proficient Rx LP	ANDA	Current
71205-417	oseltamavir phosphate	oseltamavir phosphate	Proficient Rx LP	ANDA	Current