Application 016812

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETALAR	KETAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 10MG BASE/ML	Yes	Yes
002	KETALAR	KETAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 50MG BASE/ML	Yes	Yes
003	KETALAR	KETAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 100MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS
N016812-001	KETALAR	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016812-002	KETALAR	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N016812-003	KETALAR	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016812-001	AP
N016812-002	AP
N016812-003	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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N016812-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016812-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016812-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016812-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016812-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016812-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016812-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016812-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016812-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016812-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016812-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016812-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016812-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016812-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016812-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016812-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016812-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016812-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016812-001	AP	1	`79d66fd596c7…`

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
Ketalar	KETAMINE HYDROCHLORIDE	Par Health USA, LLC	14e8f864-8b8a-4e7e-8439-e510d3107063	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016812 application number: NDA016812 ndc (product): 42023-114 ndc (product): 42023-115 ndc (product): 42023-113
KETALAR	KETAMINE HYDROCHLORIDE	Henry Schein, Inc	46dab560-8ecd-4d92-8c92-6baa2310b09b	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016812 application number: NDA016812 ndc (product): 0404-9880

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9880	KETALAR	ketamine hydrochloride	Henry Schein, Inc	NDA	Current
0404-9880	KETALAR	ketamine hydrochloride	Henry Schein, Inc	NDA	Current
42023-113	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-113	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-113	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-113	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-114	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-114	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-114	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-114	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-115	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-115	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-115	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
42023-115	Ketalar	ketamine hydrochloride	Par Pharmaceutical, Inc.	NDA	Current
52584-037	KETALAR	ketamine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-037	KETALAR	ketamine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-037	KETALAR	ketamine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-037	KETALAR	ketamine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-037	KETALAR	ketamine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-037	KETALAR	ketamine hydrochloride	General Injectables & Vac	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85520	SUPPL	2026-03-24
85519	SUPPL	2026-03-24
84026	SUPPL	2025-10-31
83999	SUPPL	2025-10-31
72046	SUPPL	2022-09-08
71253	SUPPL	2022-06-08
71218	SUPPL	2022-06-06
64409	SUPPL	2020-08-25
64402	SUPPL	2020-08-25
55139	SUPPL	2018-08-09
48217	SUPPL	2017-05-02
48189	SUPPL	2017-05-02
500	SUPPL	2012-03-13
33199	SUPPL	2012-03-09
499	SUPPL	2003-07-31