Application 040277

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	0.5%	No	Yes

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

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
A040277-001	PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040277-001	AT

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040277-001	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2000-03-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A040277-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040277-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040277-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040277-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040277-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040277-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040277-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040277-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040277-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040277-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040277-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040277-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040277-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040277-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040277-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040277-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040277-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040277-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040277-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040277-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040277-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040277-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040277-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040277-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040277-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040277-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040277-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040277-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040277-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040277-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040277-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040277-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040277-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040277-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040277-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040277-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040277-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040277-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040277-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040277-001	AT	1	`e64feba35796…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcaine	PROPARACAINE HYDROCHLORIDE	Alcon Laboratories, Inc.	0c0fa0bf-977d-4539-b8dc-54c187c5b094	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sportpharm LLC	1d257859-cd1d-485f-a4d5-dbb33c1ec197	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sportpharm LLC	509fed7b-637b-418c-93cd-19f49ba8740c	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	REMEDYREPACK INC.	55ed1359-d95c-4c2b-ad5a-cc8e023c4331	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sportpharm LLC	4ae89863-233f-4015-92da-aad0f2a87677	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine hydrochloride	PROPARACAINE HYDROCHLORIDE	Micro Labs Limited	df1af0e8-7d9d-4511-9d86-f0c31a5da2c2	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Proparacaine hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine hydrochloride	PROPARACAINE HYDROCHLORIDE	Lifestar Pharma LLC	3419104b-e847-492f-a541-a810a116c408	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Proparacaine hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
proparacaine hydrochloride	PROPARACAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9a67a989-ec6b-4a26-e053-2a95a90a826d	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: proparacaine hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Somerset Therapeutics, LLC	968a6e4e-814f-41f8-ae22-aa5a82179a6c	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	68a84d3f-a8f8-13ee-e053-2991aa0a7592	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	A-S Medication Solutions	7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261	2023-12-10	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Bausch & Lomb Incorporated	b699f838-8b69-4bac-953b-ea8822ec19fc	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sandoz Inc.	447a2a64-0507-4fe8-bb44-cc36c3916151	2022-06-29	Warnings, Adverse reactions	Name fallback brand name: Proparacaine Hydrochloride generic name: PROPARACAINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-7199	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Henry Schein Inc.	ANDA	Current
0404-7199	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Henry Schein Inc.	ANDA	Current
0404-7199	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Henry Schein Inc.	ANDA	Current
13985-611	Proparacaine Hydrochloride	Proparacaine Hydrochloride	MWI	ANDA	Current
13985-611	Proparacaine Hydrochloride	Proparacaine Hydrochloride	MWI	ANDA	Current
13985-611	Proparacaine Hydrochloride	Proparacaine Hydrochloride	MWI	ANDA	Current
17478-263	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Akorn	ANDA	Current
17478-263	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Akorn	ANDA	Current
17478-263	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Akorn, Inc.	ANDA	Current
17478-263	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Akorn, Inc.	ANDA	Current
50090-0259	Proparacaine Hydrochloride	Proparacaine Hydrochloride	A-S Medication Solutions	ANDA	Current
70518-2056	Proparacaine Hydrochloride	Proparacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17762	ORIG	2004-06-14
22112	ORIG	2003-07-31
7601	ORIG	2000-03-16