Application 216809

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	0	KETAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	No
002	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 50MG BASE/ML	No	No
003	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 100MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216809-001	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24
A216809-002	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24
A216809-003	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216809-001	AP
A216809-002	AP
A216809-003	AP

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 2 · 75 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
2026-09-14 22:38:34	2026-08	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216809-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216809-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216809-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216809-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216809-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216809-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216809-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216809-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216809-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216809-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216809-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216809-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216809-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216809-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216809-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216809-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216809-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216809-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216809-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216809-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216809-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216809-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216809-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216809-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216809-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216809-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216809-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216809-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216809-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216809-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216809-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216809-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216809-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216809-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216809-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216809-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216809-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216809-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216809-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216809-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216809-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216809-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216809-001	AP	1	`301d65b070ca…`

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
Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Gland Pharma Limited	b96a0a23-3ca0-4a92-bd8b-1e9921931772	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216809 application number: ANDA216809
Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Sagent Pharmaceuticals	902c3785-a3cb-472b-ac15-394ac646271d	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216809 application number: ANDA216809