Application 202595

Type: ANDA
Sponsor: NATCO PHARMA 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 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
A202595-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03
A202595-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03
A202595-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202595-001	AB
A202595-002	AB
A202595-003	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	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202595-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2016-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202595-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202595-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2016-08-03	`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	A202595-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202595-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202595-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202595-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202595-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202595-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202595-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202595-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202595-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202595-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202595-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202595-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202595-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202595-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202595-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202595-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202595-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202595-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202595-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202595-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202595-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202595-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202595-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202595-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	e1bec65b-4292-4110-a840-aa48053b5448	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202595 application number: ANDA202595
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Alvogen Inc.	809f859e-0852-80d3-1a67-da87ed399c15	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202595 application number: ANDA202595 ndc (product): 47781-468 ndc (product): 47781-469 ndc (product): 47781-470

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-468	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-468	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-468	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-468	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-468	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-469	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-469	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-469	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-469	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-469	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-470	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-470	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-470	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-470	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
47781-470	Oseltamivir Phosphate	Oseltamivir phosphate	Alvogen Inc.	ANDA	Current
50090-2726	Oseltamivir Phosphate	Oseltamivir phosphate	A-S Medication Solutions	ANDA	Current
53217-280	Oseltamivir Phosphate	Oseltamivir phosphate	Aidarex Pharmaceuticals LLC	ANDA	Current
63739-038	Oseltamivir Phosphate	Oseltamivir phosphate	McKesson Packaging Services	ANDA	Current
63739-038	Oseltamivir Phosphate	Oseltamivir phosphate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-044	Oseltamivir Phosphate	Oseltamivir phosphate	McKesson Packaging Services	ANDA	Current
63739-044	Oseltamivir Phosphate	Oseltamivir phosphate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-050	Oseltamivir Phosphate	Oseltamivir phosphate	McKesson Packaging Services	ANDA	Current
63739-050	Oseltamivir Phosphate	Oseltamivir phosphate	McKesson Corporation dba SKY Packaging	ANDA	Current
68071-3105	Oseltamivir Phosphate	Oseltamivir phosphate	NuCare Pharmaceuticals, Inc.	ANDA	Current
70518-0945	Oseltamivir Phosphate	Oseltamivir phosphate	REMEDYREPACK INC.	ANDA	Current
70518-0945	Oseltamivir Phosphate	Oseltamivir phosphate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45088	ORIG	2016-08-22