Application 080027

Type: ANDA
Sponsor: ALCON LABS INC

Application Products#

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

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

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
A080027-001	ALCAINE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080027-001	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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A080027-001	ALCAINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080027-001	ALCAINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080027-001	ALCAINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080027-001	ALCAINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A080027-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A080027-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080027-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080027-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080027-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080027-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080027-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080027-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080027-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080027-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080027-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080027-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080027-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080027-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080027-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080027-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080027-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080027-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080027-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080027-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080027-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080027-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080027-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080027-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080027-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080027-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080027-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080027-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080027-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080027-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080027-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080027-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080027-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080027-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080027-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080027-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080027-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080027-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080027-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080027-001	AT	1	`3a93d1ddd44b…`

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 · 5 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	Exact identifier application applno (ANDA): 080027 application number: ANDA080027 ndc (product): 0998-0016
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sportpharm LLC	1d257859-cd1d-485f-a4d5-dbb33c1ec197	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080027 application number: ANDA080027
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	REMEDYREPACK INC.	55ed1359-d95c-4c2b-ad5a-cc8e023c4331	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080027 application number: ANDA080027 ndc (product): 70518-3408
proparacaine hydrochloride	PROPARACAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9a67a989-ec6b-4a26-e053-2a95a90a826d	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080027 application number: ANDA080027 ndc (product): 68071-5139
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sandoz Inc.	447a2a64-0507-4fe8-bb44-cc36c3916151	2022-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080027 application number: ANDA080027 ndc (product): 61314-016

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0998-0016	Alcaine	proparacaine hydrochloride	Alcon Laboratories, Inc.	ANDA	Current
0998-0016	Alcaine	proparacaine hydrochloride	Alcon Laboratories, Inc.	ANDA	Current
0998-0016	Alcaine	proparacaine hydrochloride	Alcon Laboratories, Inc.	ANDA	Current
0998-0016	Alcaine	proparacaine hydrochloride	Alcon Laboratories, Inc.	ANDA	Current
0998-0016	Alcaine	proparacaine hydrochloride	Alcon Laboratories, Inc.	ANDA	Current
50090-1931	Proparacaine Hydrochloride	Proparacaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1931	Proparacaine Hydrochloride	Proparacaine Hydrochloride	A-S Medication Solutions	ANDA	Current
61314-016	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Sandoz Inc.	ANDA	Current
61314-016	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Sandoz Inc.	ANDA	Current
61314-016	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Sandoz Inc.	ANDA	Current
61314-016	Proparacaine Hydrochloride	Proparacaine Hydrochloride	Sandoz Inc.	ANDA	Current
68071-4701	Proparacaine Hydrochloride	Proparacaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4701	Proparacaine Hydrochloride	Proparacaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4701	Proparacaine Hydrochloride	Proparacaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5139	proparacaine hydrochloride	proparacaine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5139	proparacaine hydrochloride	proparacaine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3408	Proparacaine Hydrochloride	Proparacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3408	Proparacaine Hydrochloride	Proparacaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current