Application 217692

Type: ANDA
Sponsor: MANKIND PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No
003	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	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
A217692-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16
A217692-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16
A217692-003	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217692-001	AP
A217692-002	AP
A217692-003	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 · 60 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	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217692-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217692-003	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217692-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2023-06-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A217692-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217692-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217692-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217692-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217692-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217692-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217692-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217692-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217692-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217692-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217692-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217692-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217692-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217692-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217692-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217692-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217692-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217692-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217692-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217692-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217692-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217692-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217692-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217692-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217692-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217692-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217692-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217692-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217692-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217692-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217692-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217692-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217692-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217692-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217692-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217692-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217692-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217692-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217692-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217692-001	AP	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	42df73b0-20ee-d1aa-e063-6294a90aa275	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217692 application number: ANDA217692
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Lifestar Pharma LLC	8149138a-4106-4ae6-b7ad-f2559c7fa7e2	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217692 application number: ANDA217692
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NorthStar RxLLC	f065e6d2-b47e-433d-a1fb-f0449cd725f1	2024-07-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217692 application number: ANDA217692