Application 211823

Type: ANDA
Sponsor: ALEMBIC 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
A211823-001	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24
A211823-002	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24
A211823-003	OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211823-001	AB
A211823-002	AB
A211823-003	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	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211823-002	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE / ORAL	AB	2019-06-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211823-003	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211823-001	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE / ORAL	AB	2019-06-24	`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	A211823-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211823-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211823-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211823-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211823-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211823-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211823-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211823-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211823-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211823-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211823-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211823-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211823-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211823-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211823-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211823-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211823-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211823-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211823-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211823-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211823-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211823-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211823-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211823-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211823-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211823-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211823-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211823-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211823-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211823-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211823-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211823-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211823-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211823-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211823-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211823-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211823-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211823-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211823-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211823-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	82685c2f-791b-440f-a1c2-5a032da7adca	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211823 application number: ANDA211823 ndc (product): 62332-415 ndc (product): 62332-413 ndc (product): 62332-414
OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Limited	0a7181a6-e9eb-4047-a26f-4268f174db16	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211823 application number: ANDA211823 ndc (product): 46708-414 ndc (product): 46708-415 ndc (product): 46708-413

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-413	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Limited	ANDA	Current
46708-414	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Limited	ANDA	Current
46708-415	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Limited	ANDA	Current
62332-413	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-413	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-413	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-413	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-413	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-414	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-414	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-414	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-414	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-414	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-415	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-415	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-415	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-415	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-415	OSELTAMIVIR	OSELTAMIVIR	Alembic Pharmaceuticals Inc.	ANDA	Current