Application 208135

Type: NDA
Sponsor: ALCON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TETRACAINE HYDROCHLORIDE	TETRACAINE HYDROCHLORIDE	SOLUTION;OPHTHALMIC	0.5%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N208135-001	TETRACAINE HYDROCHLORIDE	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2016-02-29

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	REMEDYREPACK INC.	01fba5f8-a60a-444c-9abd-299540b8815a	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208135 application number: NDA208135
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	A-S Medication Solutions	23c40ef8-6338-46f8-aca9-1aa4f3b2207b	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208135 application number: NDA208135
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	Alcon Laboratories, Inc.	5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79	2024-01-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208135 application number: NDA208135 ndc (product): 0065-0741

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0741	Tetracaine Hydrochloride	tetracaine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0741	Tetracaine Hydrochloride	tetracaine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0741	Tetracaine Hydrochloride	tetracaine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0741	Tetracaine Hydrochloride	tetracaine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0741	Tetracaine Hydrochloride	tetracaine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
68071-5079	Tetracaine Hydrochloride	tetracaine hydrochloride	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5079	Tetracaine Hydrochloride	tetracaine hydrochloride	NuCare Pharmaceuticals,Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70364	SUPPL	2022-03-02
70311	SUPPL	2022-03-01
46037	ORIG	2016-10-27
46035	ORIG	2016-10-27
40618	ORIG	2016-03-03
32893	ORIG	2016-03-02
51682	ORIG	1900-01-01
51681	ORIG	1900-01-01
51680	ORIG	1900-01-01
51679	ORIG	1900-01-01