Application 203955

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/30ML (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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203955-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP		2016-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203955-001	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 · 43 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	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203955-001	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2016-04-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203955-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203955-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203955-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203955-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203955-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203955-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203955-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203955-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203955-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203955-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203955-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203955-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203955-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203955-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203955-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203955-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203955-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203955-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203955-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203955-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203955-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203955-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203955-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203955-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203955-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203955-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203955-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203955-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203955-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203955-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203955-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203955-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203955-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203955-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203955-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203955-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203955-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203955-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203955-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203955-001	AP	1	`f41ea6bd6efb…`

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	dff4a1e4-4b2a-4a64-b6d8-ea470dee88f7	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: ROPIVACAINE HYDROCHLORIDE
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	23d2d448-a744-4877-9f2d-7e57c198da89	2024-08-06	Warnings, Adverse reactions	Name fallback generic name: ROPIVACAINE HYDROCHLORIDE
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c6613708-c1f7-4f5c-91a3-ebbc1d7905c6	2024-07-10	Warnings, Adverse reactions	Name fallback generic name: ROPIVACAINE HYDROCHLORIDE
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	56dfabf7-f7a8-4601-b17a-cb16fb995b0f	2024-05-22	Warnings, Adverse reactions	Name fallback generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b	2024-04-18	Warnings, Adverse reactions	Name fallback brand name: Ropivacaine Hydrochloride generic name: ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	Baxter Healthcare Corporation	e057aeb2-5125-490c-b691-847426fd42d0	2023-10-10	Warnings, Adverse reactions	Name fallback brand name: ROPIVACAINE HYDROCHLORIDE generic name: ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	Baxter Healthcare Corporation	781d4b7f-7556-4695-8d48-7772d7a0d8e9	2023-06-28	Warnings, Adverse reactions	Name fallback brand name: ROPIVACAINE HYDROCHLORIDE generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine hydrochloride	ROPIVACAINE HYDROCHLORIDE	Gland Pharma Limited	643c1729-096e-459c-80c1-78b78e698da6	2022-08-22	Warnings, Adverse reactions	Name fallback brand name: Ropivacaine hydrochloride generic name: ROPIVACAINE HYDROCHLORIDE

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-081	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Akorn	ANDA	Current
17478-081	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Akorn	ANDA	Current
17478-081	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-081	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-081	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Akorn, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32482	ORIG	2016-04-13