Application 206166

Type: ANDA
Sponsor: INFORLIFE

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
004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	1GM/200ML (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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206166-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11
A206166-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11
A206166-003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11
A206166-004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A206166-001	AP
A206166-002	AP
A206166-003	AP
A206166-004	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 5 · 172 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	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206166-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206166-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206166-003	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206166-004	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	2018-06-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A206166-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206166-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206166-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206166-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206166-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206166-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206166-003	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206166-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206166-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206166-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206166-003	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206166-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206166-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206166-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206166-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206166-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206166-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206166-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206166-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206166-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206166-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206166-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206166-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206166-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206166-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206166-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206166-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206166-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206166-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206166-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206166-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206166-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206166-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206166-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206166-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206166-004	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206166-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206166-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206166-003	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206166-004	AP	1	`6a51e52b5d6a…`

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
ropivacaine hydrochloride	ROPIVACAINE HYDROCHLORIDE	Sagent Pharmaceuticals	9572b3de-684c-4028-a577-5aa69ba6b02d	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206166 application number: ANDA206166 ndc (product): 25021-671
ropivacaine hydrochloride	ROPIVACAINE HYDROCHLORIDE	Sagent Pharmaceuticals	8c5c762f-d266-4b1a-809e-f11bfc89bc2d	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206166 application number: ANDA206166 ndc (product): 25021-671 ndc (product): 25021-652

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-652	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-652	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-652	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-652	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-652	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-652	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	ropivacaine hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54894	ORIG	2018-07-16