Application 213695

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	FOR SUSPENSION;ORAL	EQ 6MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213695-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB		2025-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213695-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213695-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2025-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213695-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2025-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213695-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2025-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213695-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213695-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213695-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2025-03-03	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213695-001	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION / ORAL	AB	2025-03-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213695-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213695-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213695-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213695-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213695-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213695-001	AB	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213695-001	AB	1	`a50c72e98297…`

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 3 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oseltamivir Phosphate	OSELTAMIVIR ACID	Zydus Lifesciences Limited	7c0923ad-80b0-4134-b44a-754ea599f356	2024-12-09		Name fallback brand name: Oseltamivir Phosphate
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Lifesciences Limited	58118069-cb24-4fa3-92d7-cabdc1b027f2	2024-12-03		Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir phosphate	OSELTAMIVIR PHOSPHATE	Proficient Rx LP	37eb95bb-3142-4355-8057-4e7c78443641	2024-12-01	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate for Oral Suspension	OSELTAMIVIR PHOSPHATE	NuCare Pharmaceuticals,Inc.	27745acb-69a3-a1af-e063-6394a90ab10f	2024-11-21	Warnings, Adverse reactions	Name fallback generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	40390bf9-f2c4-4608-b5c4-315457b92821	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	7c885cfb-46a0-4e18-ab96-03031b70b9d4	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EPIC PHARMA, LLC	141c4005-89de-447e-961f-3780f62eded4	2024-09-17	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Lannett Company, Inc.	005b2784-e410-a50c-e063-6394a90a881c	2024-05-15	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate for Oral Suspension	OSELTAMIVIR PHOSPHATE	EPIC PHARMA, LLC	1b17fffc-5774-4b9b-8440-3a5295a34f89	2023-12-27	Warnings, Adverse reactions	Name fallback generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	a0f71ac9-136c-4c8d-b30d-b8d08767c206	2023-11-16	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Proficient Rx LP	8e81aaa7-7c40-4b05-b19a-cc70edd1d9f9	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Exelan Pharmaceuticals, Inc.	9fb09e82-42ef-4a2a-9bcd-3aab3ac52bb3	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	91eadf0b-5f04-4f5d-b095-02c5736a3647	2023-10-23	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Asclemed USA, Inc.	78f85d27-9935-4775-b8d7-275e11429b76	2023-09-02	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	5194bb90-0876-48c4-a967-c862fbccd110	2023-07-06	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	Lannett Company, Inc.	00e2e995-6296-b544-e063-6294a90a8345	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Cipla USA, Inc	7d04f367-8f62-4f63-bac9-717d14f555a5	2023-05-02	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals USA Inc.	432d9e7b-9cb2-4b7d-9fb2-015449096757	2023-03-13	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate	OSELTAMIVIR PHOSPHATE	A-S Medication Solutions	73d7fa5a-8304-44b7-9456-58926a265d81	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Oseltamivir Phosphate generic name: OSELTAMIVIR PHOSPHATE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	Zydus Pharmaceuticals USA Inc.	0e666061-1bfd-48cd-896b-ded8298a1847	2022-12-27	Warnings, Adverse reactions	Name fallback brand name: OSELTAMIVIR PHOSPHATE generic name: OSELTAMIVIR PHOSPHATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.