Application 205612

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	40MG/20ML (2MG/ML)	No	No
002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/100ML (2MG/ML)	No	No
003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/20ML (5MG/ML)	No	No
004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/30ML (5MG/ML)	No	No
005	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/20ML (7.5MG/ML)	No	No
006	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/10ML (10MG/ML)	No	No
007	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205612-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13
A205612-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13
A205612-003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13
A205612-004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13
A205612-005	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13
A205612-006	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13
A205612-007	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A205612-001	AP
A205612-002	AP
A205612-003	AP
A205612-004	AP
A205612-005	AP
A205612-006	AP
A205612-007	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 8 · 294 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
2026-08-18 06:07:40	2026-07	A205612-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-002	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-003	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-004	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-005	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-006	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-007	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205612-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-002	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-003	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-004	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-005	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-006	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-007	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-002	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-003	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-004	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-005	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-006	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-007	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205612-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-002	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-003	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-004	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-005	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-006	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-007	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-002	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-003	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-004	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-005	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-006	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-007	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-002	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-003	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-004	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-005	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	2016-07-13	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205612-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205612-007	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205612-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205612-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205612-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205612-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205612-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205612-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205612-005	AP	1	`b8a1b40f171c…`

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	Sportpharm LLC	7327766c-19f0-4d83-89c6-eb685e0d286c	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205612 application number: ANDA205612
Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Eugia US LLC	3763b7b6-da49-4658-b93d-28f5da24d09e	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205612 application number: ANDA205612 ndc (product): 55150-197 ndc (product): 55150-195 ndc (product): 55150-198 ndc (product): 55150-196 ndc (product): 55150-199 ndc (product): 55150-200 ndc (product): 55150-201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55150-195	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-195	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-195	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-196	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-196	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-196	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-197	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-197	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-197	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-198	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-198	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-198	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-199	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-199	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-199	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-200	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-200	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-200	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-201	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-201	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-201	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
70518-2681	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2681	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2681	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40485	ORIG	2016-07-18
10476	ORIG	2016-07-15