Application 211907

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/100ML (2MG/ML)	No	No
002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	400MG/200ML (2MG/ML)	No	No
003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	500MG/100ML (5MG/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
A211907-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15
A211907-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15
A211907-003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211907-001	AP
A211907-002	AP
A211907-003	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.

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	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211907-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211907-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211907-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2024-08-15	`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	A211907-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211907-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211907-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211907-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211907-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211907-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211907-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211907-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211907-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211907-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211907-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211907-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211907-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211907-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211907-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211907-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211907-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211907-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211907-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211907-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211907-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211907-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211907-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211907-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211907-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211907-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211907-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211907-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211907-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211907-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211907-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211907-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211907-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211907-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211907-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211907-003	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211907-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211907-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211907-003	AP	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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	3d465e02-fd09-41b8-847f-bfe99cb4a712	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211907 application number: ANDA211907