Application 012111

Type: NDA
Sponsor: ALCON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MYDRIACYL	TROPICAMIDE	SOLUTION/DROPS;OPHTHALMIC	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
004	MYDRIACYL	TROPICAMIDE	SOLUTION/DROPS;OPHTHALMIC	1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012111-002	MYDRIACYL	TROPICAMIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982
N012111-004	MYDRIACYL	TROPICAMIDE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N012111-002	MYDRIACYL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N012111-004	MYDRIACYL	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012111-002	MYDRIACYL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N012111-004	MYDRIACYL	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012111-002	MYDRIACYL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012111-004	MYDRIACYL	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N012111-002	MYDRIACYL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N012111-004	MYDRIACYL	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a50c72e98297…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tropicamide	TROPICAMIDE	Somerset Therapeutics, LLC	378b5fe2-4b5d-4c87-a7d6-fd0caa6402af	2026-04-10	Warnings, Adverse reactions	Name fallback generic name: TROPICAMIDE
Tropicamide	TROPICAMIDE	Sportpharm LLC	fc62f539-6478-4740-98ed-5e27fcfa794e	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: TROPICAMIDE
Tropicamide	TROPICAMIDE	Bausch & Lomb Incorporated	892b78c8-36bc-47d3-850e-502899b48fb9	2023-09-01	Warnings, Adverse reactions	Name fallback generic name: TROPICAMIDE
Mydriacyl	TROPICAMIDE	Alcon Laboratories, Inc.	0d4f4a2e-eb00-4c65-b3fa-baf5738d468d	2023-02-15	Warnings, Adverse reactions	Name fallback brand name: Mydriacyl generic name: TROPICAMIDE
Mydriacyl	TROPICAMIDE	Alcon Laboratories, Inc.	57165763-29dc-4812-b840-a8a5086416f3	2022-12-22	Warnings, Adverse reactions	Name fallback brand name: Mydriacyl generic name: TROPICAMIDE
Tropicamide	TROPICAMIDE	Sandoz Inc	0104ffe4-013d-4afa-996d-dcba4f08e93d	2022-06-29	Warnings, Adverse reactions	Name fallback generic name: TROPICAMIDE
Tropicamide	TROPICAMIDE	Sandoz Inc	521592d1-53a1-4314-8b3f-d808f3bccfcd	2022-01-26	Warnings, Adverse reactions	Name fallback generic name: TROPICAMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.