Application 090318

Type: ANDA
Sponsor: MYLAN ASI

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	150MG/30ML (5MG/ML)	No	No
003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/20ML (7.5MG/ML)	No	No
004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	No	No

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

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	Approval date
A090318-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23
A090318-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23
A090318-003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23
A090318-004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090318-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	2014-09-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090318-002	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	2014-09-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090318-003	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	2014-09-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090318-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	2014-09-23	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090318-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090318-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090318-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090318-004	AP	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A090318-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090318-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090318-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090318-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090318-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090318-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090318-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090318-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090318-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090318-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090318-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090318-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090318-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090318-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090318-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090318-004	AP	1	`ea99ee380514…`

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 ndc (product): 25021-671
ropivacaine hydrochloride	ROPIVACAINE HYDROCHLORIDE	Sagent Pharmaceuticals	8c5c762f-d266-4b1a-809e-f11bfc89bc2d	2025-08-06	Warnings, Adverse reactions	Exact identifier 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
25021-653	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-671	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Sagent Pharmaceuticals	ANDA	Current
67457-875	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-875	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-875	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-876	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-876	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-876	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-877	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-877	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-877	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-878	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-878	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-878	Ropivacaine Hydrochloride	ropivacaine hydrochloride	Mylan Institutional LLC	ANDA	Current