Application 209438

Type: ANDA
Sponsor: HETERO LABS LTD III

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
A209438-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23
A209438-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23
A209438-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209438-001	AB
A209438-002	AB
A209438-003	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	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209438-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2018-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209438-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209438-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2018-02-23	`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	A209438-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209438-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209438-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209438-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209438-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209438-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209438-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209438-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209438-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209438-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209438-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209438-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209438-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209438-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209438-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209438-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209438-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209438-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209438-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209438-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209438-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209438-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209438-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209438-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209438-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209438-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209438-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209438-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209438-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209438-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209438-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209438-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209438-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209438-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209438-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209438-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209438-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209438-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209438-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209438-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Sportpharm LLC	a8a40f98-f6bd-4ef0-af03-93ed0f473c10	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209438 application number: ANDA209438
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	REMEDYREPACK INC.	ad90fe42-8d52-403e-9b07-b8536fbf335a	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209438 application number: ANDA209438 ndc (product): 70518-3247
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	a0f71ac9-136c-4c8d-b30d-b8d08767c206	2023-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209438 application number: ANDA209438 ndc (product): 50090-6099
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Proficient Rx LP	8e81aaa7-7c40-4b05-b19a-cc70edd1d9f9	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209438 application number: ANDA209438
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Asclemed USA, Inc.	00be0870-2ebb-46e3-9e98-a8f068ec664a	2022-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209438 application number: ANDA209438 ndc (product): 76420-290 ndc (product): 76420-289 ndc (product): 76420-291
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Proficient Rx LP	1f754ad7-9df0-4121-8051-0a09491be3c7	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209438 application number: ANDA209438 ndc (product): 71205-617
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Proficient Rx LP	8d264c73-4dd9-4f7c-8a18-f31195cdd013	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209438 application number: ANDA209438 ndc (product): 71205-680
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Camber Pharmaceuticals, Inc.	2a673aa2-e8f0-4aa4-8782-6fb3067ff108	2018-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209438 application number: ANDA209438 ndc (product): 31722-632 ndc (product): 31722-630 ndc (product): 31722-631

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-817	Oseltamivir Phosphate	Oseltamivir Phosphate	NorthStar RxLLC	ANDA	Current
16714-818	Oseltamivir Phosphate	Oseltamivir Phosphate	NorthStar RxLLC	ANDA	Current
16714-819	Oseltamivir Phosphate	Oseltamivir Phosphate	NorthStar RxLLC	ANDA	Current
31722-630	Oseltamivir Phosphate	Oseltamivir Phosphate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-631	Oseltamivir Phosphate	Oseltamivir Phosphate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-632	Oseltamivir Phosphate	Oseltamivir Phosphate	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-4890	Oseltamivir Phosphate	Oseltamivir Phosphate	A-S Medication Solutions	ANDA	Current
50090-6099	Oseltamivir Phosphate	Oseltamivir Phosphate	A-S Medication Solutions	ANDA	Current
50090-6099	Oseltamivir Phosphate	Oseltamivir Phosphate	A-S Medication Solutions	ANDA	Current
68071-2528	Oseltamivir Phosphate	Oseltamivir Phosphate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2528	Oseltamivir Phosphate	Oseltamivir Phosphate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2754	Oseltamivir Phosphate	Oseltamivir Phosphate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3247	Oseltamivir Phosphate	Oseltamivir Phosphate	REMEDYREPACK INC.	ANDA	Current
71205-617	Oseltamivir Phosphate	Oseltamivir Phosphate	Proficient Rx LP	ANDA	Current
71205-617	Oseltamivir Phosphate	Oseltamivir Phosphate	Proficient Rx LP	ANDA	Current
71205-680	Oseltamivir Phosphate	Oseltamivir Phosphate	Proficient Rx LP	ANDA	Current
76420-289	Oseltamivir Phosphate	Oseltamivir Phosphate	Asclemed USA, Inc.	ANDA	Current
76420-290	Oseltamivir Phosphate	Oseltamivir Phosphate	Asclemed USA, Inc.	ANDA	Current
76420-291	Oseltamivir Phosphate	Oseltamivir Phosphate	Asclemed USA, Inc.	ANDA	Current