Application 088447

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TROPICAMIDE	TROPICAMIDE	SOLUTION/DROPS;OPHTHALMIC	1%	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
A088447-001	TROPICAMIDE	TROPICAMIDE	1%	SOLUTION/DROPS / OPHTHALMIC			1985-08-28

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	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A088447-001	TROPICAMIDE	1%	SOLUTION/DROPS / OPHTHALMIC	1985-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088447-001	TROPICAMIDE	1%	SOLUTION/DROPS / OPHTHALMIC	1985-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088447-001	TROPICAMIDE	1%	SOLUTION/DROPS / OPHTHALMIC	1985-08-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088447-001	TROPICAMIDE	1%	SOLUTION/DROPS / OPHTHALMIC	1985-08-28	`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 brand name: Tropicamide generic name: TROPICAMIDE
Tropicamide	TROPICAMIDE	Sportpharm LLC	fc62f539-6478-4740-98ed-5e27fcfa794e	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Tropicamide generic name: TROPICAMIDE
Tropicamide	TROPICAMIDE	Bausch & Lomb Incorporated	892b78c8-36bc-47d3-850e-502899b48fb9	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: Tropicamide generic name: TROPICAMIDE
Mydriacyl	TROPICAMIDE	Alcon Laboratories, Inc.	0d4f4a2e-eb00-4c65-b3fa-baf5738d468d	2023-02-15	Warnings, Adverse reactions	Name fallback generic name: TROPICAMIDE
Mydriacyl	TROPICAMIDE	Alcon Laboratories, Inc.	57165763-29dc-4812-b840-a8a5086416f3	2022-12-22	Warnings, Adverse reactions	Name fallback generic name: TROPICAMIDE
Tropicamide	TROPICAMIDE	Sandoz Inc	0104ffe4-013d-4afa-996d-dcba4f08e93d	2022-06-29	Warnings, Adverse reactions	Name fallback brand name: Tropicamide generic name: TROPICAMIDE
Tropicamide	TROPICAMIDE	Sandoz Inc	521592d1-53a1-4314-8b3f-d808f3bccfcd	2022-01-26	Warnings, Adverse reactions	Name fallback brand name: Tropicamide generic name: TROPICAMIDE

Reported adverse events (FAERS/openFDA)#

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