Application 085555

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AK-PENTOLATE	CYCLOPENTOLATE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A085555-001	AK-PENTOLATE	CYCLOPENTOLATE HYDROCHLORIDE	1%	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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A085555-001	AK-PENTOLATE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085555-001	AK-PENTOLATE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085555-001	AK-PENTOLATE	1%	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclogyl	CYCLOPENTOLATE HYDROCHLORIDE	Alcon Laboratories, Inc.	1d008c76-7210-4ace-90fa-7cd22762e12e	2024-06-25	Warnings, Adverse reactions	Name fallback generic name: CYCLOPENTOLATE HYDROCHLORIDE
Cyclopentolate Hydrochloride	CYCLOPENTOLATE HYDROCHLORIDE	Bausch & Lomb Incorporated	ad85b220-6003-4a78-b900-5195ceaf0fd5	2022-09-29	Warnings, Adverse reactions	Name fallback generic name: CYCLOPENTOLATE HYDROCHLORIDE
Cyclopentolate Hydrochloride	CYCLOPENTOLATE HYDROCHLORIDE	Sandoz Inc.	c1b44f91-356d-4804-9509-3b457f4809e5	2022-06-21	Warnings, Adverse reactions	Name fallback generic name: CYCLOPENTOLATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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